Snuggle Hot Water bottles with cover (assorted) (updated)
The hot water bottles do not have the required safety warning permanently marked on them according to the mandatory standard for hot water bottles.
AUSTRALIAN RECALL CATEGORY
Pharmacy and medical products recalls.
221 archived Australian notices, each linked to its official Product Safety Australia source. The page updates automatically when new notices arrive.
IGP Sports HR40 heart rate monitor
The products were sold without the warning information that is required for products containing button/coin batteries.
500ml Essential Oil Distillation Kit
The mesh plate the flask sits on may contain asbestos. There is a risk of exposure to asbestos fibres when using this product.
Mon Chateau Comfort Gel Mat
The corners of some mats may lift up or curl, creating a trip hazard.
UEBE Domotherm rapid REF0830
The product does not comply with the mandatory safety standard for products containing button/coin batteries . The packaging does not display the required warning label and does not display treatment advice in case of ingestion.
Shred Maxx, Shred Maxx Male, Shred Maxx Super Strength, Glow Maxx, Cli Maxx, X Maxx and GMax supplement capsules
These products were supplied within Australia for therapeutic use, without being registered on the Australian Register of Therapeutic Goods (ARTG). These products have not been assessed as required, so their safety and efficacy are unknown. For example, Glow Maxx is noted on the label to contain 1000 micrograms (mcg) of Vitamin D per capsule (per day). Medicines in Australia require a prescription if they contain more than 25 micrograms of Vitamin D per recommended daily dose. 1000 micrograms per day is 40 times this amount and, after prolonged use, could result in toxic effects such as vomiting and diarrhoea.
Fu Gui Ba Wei Tang a.k.a. Rehmannia Eight Vitality Formula & Nuan Gong Cheng Yun Fang a.k.a. Motherhood 1 Formula
These two products contain fennel as an active ingredient. The label on the bottle does not include mandatory wording required for pregnancy and children warning statements.
Young Living ComforCleanse laxatives
ComforCleanse contains an extract from Foeniculum vulgare (fennel). The label on the bottle does not include mandatory wording required for pregnancy and children warning statements.
Accu-Chek Solo Cannula Assembly & Pump Holder and Accu-Chek Solo Supply Kit
Insulin leakage has occurred with the Accu-Chek Solo Cannula Assembly and Pump Holder. If the insulin leakage is not immediately noticed when using the Accu-Chek Solo system this could potentially lead to an under-delivery of insulin.
BiPAP A40, DreamStation, BiPAP A30, BiPAP Auto System One 60 Series, BiPAP AVAPS C Series, BiPAP A40 Pro, Trilogy Evo, REMstar, SIMPLYGO and Elegance devices
The power cord supplied in affected products does not comply with requirements in the Medical electrical equipment standard IEC60601-1.
Aspire Superlite Adjustable Seat Walker
The nut securing the frame’s cross brace in place may become loose over time, leading to the frame becoming unstable.
Detox + Debloat
Detox + Debloat tablets contains an extract from Foeniculum vulgare (fennel seeds). The bottle does not have required pregnancy and children warning statements on the label.
Vicks VapoRub Xtra Strong 100g
Some 100g jars of Vicks VapoRub Xtra Strong in batch number 222605 have been incorrectly labelled as Vicks VapoRub.
DreamWear Full Face Mask, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks and Wisp Youth Nasal Masks, Amara View Minimal Contact Full-Face Mask and Therapy Mask 3100 NC/SP
The affected masks contain magnets which can potentially affect the functioning of implanted medical devices such as metal splinters in the eyes, brain shunts, aneurysm clips, pacemakers, implantable cardioverter defibrillators, defibrillators, VP shunts, and neurostimulators used in and around the neck or any implanted medical device impacted by magnetic fields. Philips Respironics is updating the existing contraindications and warnings on the Instructions For Use (IFU) to strengthen the current labelling and warnings related to magnets.
Sanjin Watermelon Frost Insufflation
The instructional leaflet enclosed with the bottle contains diagrams showing how to use the product safely. One diagram is shown out of order and with no context, this may result in users incorrectly removing the dosing component from the bottle and pouring the powder out unrestricted.
Omnipod DASH Personal Diabetes Manager (PDM)
The product's battery pack may swell, leak fluid or overheat and could catch on fire.
Dasatinib Dr. Reddy's dasatinib 50 mg film coated tablet blister pack and Dasatinib Dr. Reddy's dasatinib 100 mg film coated tablet blister pack
The tablet may not dissolve properly and this can result in incomplete release of the medicine.
BiPAP A40 Ventilator
Certain devices were built with motor assemblies that may contain non-conforming plastic material.
Lucas’ Papaw Ointment 15g, 75g, 200g
The recall is due to microbial ( Aspergillus tubingensis, Sordaria humana, Penicillium paneum and Paenibacillus glucanolyticu s) contamination.
All MiniMed 640G, 670G, 700, 770G, and 780G Insulin Pumps
The gold battery cap contact may fall off when the user is charging the battery. If the contact falls off, the 'Insert battery' alarm will not clear automatically when the user inserts a new AA battery as the circuit is not complete. This will result in the alarm escalating to a siren and then the pump will shut down and will not power up.
t:slim X2 Insulin Pump
The insulin pump may experience software issues which may disrupt insulin delivery.
Kynd Stress Relief Tablets 30's
Reports of allergic reaction.
ABS6090 AEROBURN PE Burn Sheets, 60 cm x 90 cm
The seals on some of the product may become damaged or broken when handled. If the seal on the pouch opens before use, the dressing may lose its microbiological barrier and become non-sterile.
Trustcare Outdoor Rollators - Trustcare Let's Go Out
The backrest of outdoor rollators may break. The current version of the products Information For Use does not contain any warning to ensure correct use and maintenance of the product.
Havyco Vy & Tea 45g
The product contains the undeclared substances phenolphthalein and sibutramine. The products were supplied without an active Australian Registry for Therapeutic Goods (ARTG) registration.
EleCare, Similac and Alimentum Infant Formula 400g
The recall is due to potential microbial contamination ( Cronobacter and Salmonella ).
Flordis Ellura Capsules
Batch N0121301 of the hard capsule shells contain ethylene oxide (ETO).
NovoMix 30 Penfill
The instructions inside the product has incorrect labelling: The customer medicine information has incomplete description of the active ingredient and its appearance. The pack insert incorrectly states: ‘Do not keep the NovoMix® 30 Penfill® that you are using, or that you are carrying as a spare, with you. The storage conditions are correctly stated on the product carton. The correct statement reads: ‘You can carry the NovoMix® 30 Penfill® that you are using, or that you are carrying as a spare, with you. You can keep it at room temperature (not above 30°C) or in a refrigerator (2°C - 8°C) for up to 4 weeks.’
NovoRapid FlexPen
The storage instructions inside the product has incorrect labelling. The pack insert incorrectly states: ‘Do not keep the NovoRapid® FlexPen® that you are using, or that you are carrying as a spare, with you. The storage conditions are correctly stated on the product carton. The correct statement reads: ‘You can carry the NovoRapid® FlexPen® that you are using, or that you are carrying as a spare, with you. You can keep it at room temperature (not above 30°C) or in a refrigerator (2°C - 8°C) for up to 4 weeks.’
Fiasp FlexTouch
The storage instructions inside the product has incorrect labelling. The pack insert incorrectly states: ‘Do not keep the Fiasp® FlexTouch® that you are using, or that you are carrying as a spare, with you. The storage conditions are correctly stated on the product carton. The correct statement reads: ‘You can carry the Fiasp® FlexTouch® that you are using, or that you are carrying as a spare, with you. You can keep it at room temperature (not above 30°C) or in a refrigerator (2°C - 8°C) for up to 4 weeks.’
Wireless Recharger Model WR9220 and WR9200 for Rechargeable Implanted Neurostimulator
The Medtronic WR9220 and WR9200 Rechargers may become unresponsive when: the product is fully depleted; and placed on the dock; and quickly removed within 20 seconds, interrupting the initialisation routine. When the Wireless Recharger becomes unresponsive, the Wireless Recharger: will not respond to a button press cannot pair with the recharger app the recharger battery indicator will flash continuously when placed on the battery dock.
Invacare Perfecto2 V Oxygen Concentrator
The sound abatement washer may break down resulting in metal on metal wear inside the Pressure Equalisation (PE) valve. This may lead to high temperatures and overheating, separation of the shroud from the device, and loud noise, and can result in a fire that will shut down the device.
Lidocaine Hydrochloride Topical Solution USP, 4%, 50mL
The Lidocaine Hydrochloride topical solution can become stronger than intended.
Althea THC18
The level of tetrahydrocannabinol (THC) in this batch is too low and outside of the labelled concentration.
MiniMed Remote Controller MMT-503 used with MiniMed 508 Insulin Pump or Paradigm Pumps
An unauthorised individual in close proximity to an insulin pump user could potentially copy the wireless RF signals from the user’s remote controller and play those back later to deliver an additional bolus of insulin to the pump user or to suspend insulin delivery.
mySugr Bolus Calculator App (on Android)
When multiple devices are used on one account and certain changes in setting are made, a software bug on an Android device may cause the app to recommend an incorrect insulin reading.
DS Maref LX9 Sequential Pneumatic Compression Device
A fault in the programming of the LX9 pumps, may cause users to experience higher pressure in the garments than set on the device.
The Neuro Zti EVO and CLA Cochlear Implants
The implant may stop working due to a complete loss of communication between the implant and the sound processor.
MiniMed 640G and 670G Insulin Pumps
If the pump retainer ring breaks, the reservoir may become loose and may not lock into the pump.
MIC Gastrostomy Feeding Tubes - expanded recall
The Instructions For Use leaflet was not supplied with the product. The Instructions For Use provide important safety information for the user.
Trilogy Evo O2 and Trilogy Evo Portable Ventilators
Two software issues have been identified that relate to a pressure increase in the ventilators. 1. Infant/Pediatric External Flow Sensor (EFS) Calibration Pressure increase. An increase in the expiratory pressure (EPAP/PEEP) can occur when the paediatric/infant External Flow Sensor is used with an Active Flow or Dual Limb circuit and a manual circuit calibration is performed. 2. Pressure Drift (Continuous Usage). When a Trilogy Evo or Trilogy Evo O2 model is used continuously without any interruption to therapy, the baseline pressure may increase or decrease.
Philips M5072A Infant/Child SMART Pads Cartridge - External Defibrillator Electrode
Certain M5072A Infant/Child SMART Pads Cartridges (LOT Number Y111220-01) contain an incorrect image underneath the PULL handle on the protective cover that shows the pad placement for an adult’s chest (Figure 2). The image on the protective cover should show a drawing of pad placement for a child’s chest and back (Figure 1). The image is correct on the outer pouch that contains the infant/child pads cartridge (Figure 3).
Ruzurgi Amifampridine 10 mg Tablet Bottle
The affected product batch 18039 exceeds the specification for total yeast and mould counts (TYMC).
Cerabone Granules and Mucoderm (multiple sizes)
The product's patient information leaflet and patient implant card have been left out when the products were supplied. The implantation card and patient information sheet provide traceability of the products and important safety information for the patient.
DuoDERM Extra Thin and DuoDERM CGF adhesive wound dressings
The packaging of the adhesive wound dressings is not sealed together completely, leaving partial or fully open seals. The product may become non-sterile if the seal is open.
Sym Balance 90 Tablets
Bottles in affected batch number 754020 are mislabelled. These bottles may contain Para Tone multi-vitamin tablets instead of Sym Balance multi-vitamin tablets.
Manjistadi Kashyam, Mahanarayana Oil, Kottamchukkadi Oil and Ayyapala Oil
The products were supplied in the Australian market without an active Australian Registry for Therapeutic Goods (ARTG) registration and which were also labelled to contain Azadirachta indica ‘Neem’, Melia azdarach, or Acorus calumus.
Configura Advance Chairs
The backrest may detach from the chair.
BOC LIFE LINE Emergency Oxygen Resuscitation Kit
The BOC LIFE LINE Emergency Oxygen Resuscitation Kit includes two modules inside the bag; a 'Standard Module' (Blue pouch)’ and a 'Professional Module (Yellow pouch)’. Each module contains one adult and one child size oxygen mask. For Batch No.0462/0423 only, the oxygen masks in the ‘Professional Module' are missing the connector piece between the mask and the tubing. As a result, the tubing is not able to connect to the mask. Oxygen will not be able to be administered using the masks in the ‘Professional Module’. The ‘Standard module' is able to be used fully.
Philips Respironics - Certain CPAP and Bi-Level PAP Devices
The polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators may: 1. Degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2. Emit certain chemicals (volatile organic compounds or VOCs).
Philips Respironics - Certain Ventilator Devices
The polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous Ventilators may: 1. Degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2. Emit certain chemicals (volatile organic compounds or VOCs)
Hydralyte Strawberry Kiwi Flavoured Effervescent Electrolyte 20 Tablets
The product contains Carthamus tinctorius flower (safflower flower) extract, as an inactive ingredient, but does not include the required pregnancy warning label.
Clinell Universal Wipes
The affected batches are contaminated with a low level of Burkholderia cepacia bacteria.
M8 and S8 Lead Adaptors
Certain patients who have been implanted with S8 (SADP2008-25(B)) or M8 (MADP2008-25(B)) Lead Adaptors received implant cards (patient ID cards) that incorrectly indicate the system is 'MR Conditional', systems with these lead adaptors should be identified as 'MR Unsafe'. The M8 and S8 Lead Adapters of the implanted Senza system are not MR Conditional. The M8 and S8 Lead Adaptors are correctly noted as MR unsafe in the MRI manual.
Thankyou Thick & Soft Baby Wipes Value Pack
Wipes with the affected timestamp within the affected batch of baby wipes was manufactured without preservative. As a result, mould may grow on the baby wipes.
Nimbus 4 and Nimbus Professional Mattresses
Nimbus 4 and Nimbus Professional mattresses may over-inflate, due to an inner mattress component failure. This cannot be detected until the product is disassembled.
E-PRIME Vitamin E Gel Capsules 60
The E-Prime Vitamin E Gel Capsules could contain trace amounts of sulphites. The labels of the affected product do not state that the capsules contain sulphites.
LIFEPAK CR2 Defibrillator
The LIFEPAK CR2's lid magnet may dislodge from the device. The lid magnet is the primary means by which the device will turn on and off when the lid is opened or closed. If the battery dislodges: 1. The battery may be depleted prematurely, even if the device is not powered on; and 2. Users may not be able to turn the device on if they do not use the on/off button or if the battery has fully depleted.
Medcure Herbal Products containing Acorus calamus
The products were supplied in the Australian market without an Australian Registry for Therapeutic Goods (ARTG) registration and were also labelled to contain Acorus calamus .
Flocare Infinity II Enteral Feeding Pumps
In a situation where the device is not plugged into the main power supply and when running on battery power only, the device may unexpectedly switch off without sounding the alarm to indicate a low battery charge. This issue only affects Flocare Infinity Enteral Feeding Pumps. It does not affect any other Nutricia products.
Roche Diabetes mySugr Bolus Calculator App
A software bug may cause the app to recommend an incorrect amount of insulin where: 1. The user used exchanges as carb display unit (not grams); and 2. The user has set an amount of grams per exchange to something different from the regional default setting (e.g. 10 grams instead of region default of 12 grams).
Westlab Reusable Medical Face Shield
The Instructions for Use (IFU) have been updated to include additional wording: For protection against airborne particles that may be present in the environment due to aerosol-generating procedures (AGP), Westlab recommends wearing a face mask and/or safety eyewear for additional protection.
MyWay Walker Chassis
The rear legs of the walker have a small cylindrical mounting feature called a boss, which the castors are screwed into. If the welding is not sufficient between the leg and the boss, the boss can come loose and the castors will detach from the rear legs of the chassis.
AntiBioBotanical and Ly)mex
The Therapeutic Goods Administration (TGA) has undertaken a review of the safety of the ingredient Artemisia, and has formed the view that the safety of listed medicines containing Artemisia species may pose a risk when used by consumers who are pregnant, or likely to become pregnant.
Good Life Nutrition/Wealthy Health - Super Urinary Gout Support
The Therapeutic Goods Administration (TGA) has undertaken a review of the safety of the ingredient Artemisia and has formed the view that the safety of listed medicines containing Artemisia species may pose a risk when used by consumers who are pregnant or likely to become pregnant.
Enhanced Enlite Sensor (MMT-7008) and Guardian Sensor 3 (MMT- 7020) Glucose Monitoring System
The sensors may show falsely elevated sensor glucose readings for users who are taking hydroxyurea, an anti-neoplastic drug, used primarily in chemotherapy. Incorrect glucose readings may result in incorrect diabetes treatment decisions.
BioCeuticals Paracea Forte (60)
The Therapeutic Goods Administration (TGA) has undertaken a review of the safety of the ingredient Artemisia , and has formed the view that the safety of listed medicines containing Artemisia species may pose a risk when used by consumers who are pregnant, or likely to become pregnant.
Hilde Hemmes' Herbals Wormwood Herb 50g
The Therapeutic Goods Administration (TGA) has undertaken a review of the safety of the ingredient Artemisia and has formed the view that the safety of listed medicines containing Artemisia species may pose a risk when used by consumers who are pregnant or likely to become pregnant.
Dexcom G4 Platinum, G5 Mobile and G6 Sensor Glucose Monitoring System
The Dexcom Continuous Glucose Monitoring System may show falsely elevated glucose readings for users who are taking hydroxyurea, an anti-neoplastic drug, used primarily in chemotherapy. Incorrect glucose readings may result in incorrect diabetes treatment decisions.
T34 Syringe Pump
The voltage of the 9V/6LR61 battery may drop prematurely or earlier than expected in T34 2nd and 3rd edition devices. This may cause an interruption to the infusion, following events of: 1. Premature 'low battery' or 'end battery' alarms 2. Unexpected pump shut down with or without alarm. Battery brands/lots that have lower and more stable internal resistance are not likely to cause significant voltage dips and therefore not likely to trigger early low/end battery alarms or pump shut down.
Metagenics Parex and Metagenics Costat
The Therapeutic Goods Administration (TGA) has undertaken a review of the safety of the ingredient Artemisia, and has formed the view that the safety of listed medicines containing Artemisia species may pose a risk when used by consumers who are pregnant or likely to become pregnant.
Immune RX 90 Capsules
The Therapeutic Goods Administration (TGA) has undertaken a review of the safety of the ingredient Artemisia, and has formed the view that the safety of listed medicines containing Artemisia species may pose a risk when used by consumers who are pregnant, or likely to become pregnant.
Gloria Herbs - Liver Detox
The Therapeutic Goods Administration (TGA) has undertaken a review of the safety of the ingredient Artemisia, and has formed the view that the safety of listed medicines containing Artemisia species may pose a risk when used by consumers who are pregnant, or likely to become pregnant.
MediHerb Stealth Complex 60 Tablets
The Therapeutic Goods Administration (TGA) has undertaken a review of the safety of the ingredient Artemisia, and has formed the view that the safety of listed medicines containing Artemisia species may pose a risk when used by consumers who are pregnant or likely to become pregnant.
Peak Carbonlite Rollator
The attachment of the front castor bolt is inadequate and does not allow bonding to the laminate. If the walker is pushed with force into a gutter or similar obstacle, this can cause the wheel to detach.
Liko Multirall Q-link Strap Lock
If the Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by users, this can lead to the Multirall lift becoming detached from the rail system.
Tenofovir Disoproxil Emtricitabine Mylan 300/200 Tablets
Potential for broken and/or split tablets. In the event a broken/split tablet is consumed, this may result in an ineffective dose if the tablet is not taken in its entirety.
Infants' Friend Oral Liquid 100mL
When used at high doses or for prolonged periods, the product can expose children to higher than safe levels of chloroform.
Alpha Active 3, Alpha Active 4 and Alpha Active 5 Medical Pump
The mains cables may become damaged through incorrect stowage or misuse.
RevMedx Trauma Dressing (RTD) - Sterile Non-woven Gauze Pad supplied in Shark Bite/Major Haemorrhage Kit
There may be damage to the package seal of the RevMedx Trauma Dressing (RTD). If the package seal is damaged the Trauma Dressing product may become non-sterile.
CareLink Personal Software and CareLink System
A software defect in CareLink Uploader Build 3.1.2 to 3.1.5, may lead to data uploads to the CareLink Personal and CareLink system software being affected by RF interference from surrounding equipment and result in the following: 1. The report may be missing all basal rates that are programmed in the device, and the 24-hour basal total will appear to be incorrectly blank. 2. The report may only display certain programmed basal rates and some other basal rates that are programmed in the device may be missing from the report. This will result in a miscalculation on the Device Settings report of the 24 -hour basal total. Actual delivered insulin calculations in all reports are not impacted, including total daily dose and total basal delivery.
White Knight Antibacterial Hand Sanitiser 500mL and White Knight Sweet Berry Antibacterial Hand Sanitiser 500mL
The product contains less than the 70% or 75% alcohol content that is detailed on the product's label.
CareLink (CL) Software and CL System using CareLink Reports
Following an update to CareLink software on 29 August, 2020, consumers who generated a report from CareLink Personal or CareLink system software may have been presented with an inaccurate carbohydrate ratio setting on their CareLink report. This only occurred under the following circumstances: 1. The carbohydrate unit of measurement in CareLink software is set to grams, but the insulin pump is set to exchanges. 2. The carbohydrate unit of measurement in CareLink software is set to exchanges, but the insulin pump is set to grams.
Laerdal Compact Suction Unit (LCSU) 4
The pump of the affected units may malfunction resulting in low suction levels or failure to provide suction.
DM36 Dreama Slim Support Pad for Jenx Dreama Sleep Mattress
The inserts that attach the small PU pad to the bracket are manufactured from plywood sheet material that may contain structural defects. This reduces the strength of the fitting, which can result in the plywood splitting and the support pad breaking off the bracket. Breakage may occur without warning and the affected items cannot be easily identified upon inspection.
Hydroframe with Manuka Honey
Some products have been released without a statement on the label identifying that the product contains Manuka Honey.
Perfect Dry Lux
Some products had previous versions of the manual that did not include the manufacturer's details in the manual or label. The Function details section of the manual states 'UV-C disinfectant'. The claim of disinfectant is being removed as it is not intended to disinfect the hearing aid.
Aerowipe Cleansing Wipes Supplied in Various First Aid Kits
Recall due to the visual presence of black spots resembling mould growth. No other batches of Aerowipe Cleansing Wipes are affected by this recall.
Kingston Mobile Chair 18005SMB and 18005SMF
The chair is labelled with a maximum user weight of 160kg. Testing has shown that at a weight of around 130kg, the leg members of the chair may deform and that with continued use the chair may eventually collapse. The chair's maximum user weight is 130kg.
Tandem t:slim X2 Insulin Pump and t:slim X2 Insulin Pump with Basal-IQ Technology
Consumers may experience unexpected fluctuation of the remaining battery life of their pump. During high battery usage, the pumps displayed battery life may appear to fluctuate. For example during a basal or bolus delivery, the displayed battery life may temporarily decrease, but normalises to display a higher value once insulin delivery is completed. This may be confusing to users. The fluctuating battery life display does not affect insulin delivery, and the pump will continue delivering insulin as long as there is at least 1% of battery remaining.
Bellman & Symfon Flash Receiver
If the backup batteries have been depleted and a fire occurs during power loss, the Flash Receiver will not produce an alert.
MyCareLink Relay Home Communicator
A software update on 17 July 2020 caused a data connectivity disruption to the MyCarelink software. As a result data transmissions, including CareAlerts, are disabled between the Communicator and the CareLink Network. This issue results in the inability for a Relay communicator to transmit implanted device data to the CareLink Network and persists until the Relay is power cycled for any reason. There is no impact to users implanted device or data from that device.
KOO 2L Hot Water Bottle
The hot water bottles may not meet the performance requirements of the 'Trade Practices (Consumer Product Safety Standard) (Hot Water Bottles) Regulations 2008'. The stopper could leak or seams could split.
BioCeuticals Vitamin D3 Drops Forte Liquid 20mL
The concentration of active ingredient may not be uniform throughout the batch of product. Different bottles may have different levels of active constituent and some bottles may fail to meet the label claim. The liquid may appear transparent/clear rather than the expected opaque white.
Guardian Connect iOS App CSS7200
Reports of data connectivity disruptions to the CareLink software. As a result, the following disruptions may occur: Care partners may not receive SMS alerts from the Guardian Connect app; Care partner remote access monitoring in the CareLink Connect web app may show data gaps; or Users may see data gaps in CareLink reports. Normal use of the Guardian Connect app is not impacted and users will still be able to view CGM data and receive alerts in the Guardian Connect app.
DM36 Dreama Slim Support Pad for Jenx Dreama Sleep Mattress
The inserts that attach the small PU pad to the bracket may have been inserted the wrong way around. This reduces the strength of the fitting which can result in the support pad breaking off the bracket when placed under pressure.
Fusion Comfort Chair
The chair is labelled with a maximum user weight of 200kg. Testing has shown that at a weight of around 110kg, there was a potential for weld failure in the base assembly and if occupied, the chair could collapse. The chair's maximum user weight is 110kg.
HiLite Chair
The chair is labelled with a safe working limit of 200kg, testing showed that at a weight of around 150kg there was a potential for weld failure in the frame and if occupied the chair back could collapse. The chair's safe working limit is 130kg.
SS Casino Dry Gin 700mL
The product is labelled as gin, however it is not gin, the bottle contains hand sanitiser. The recall is due to non-compliant labelling (NIP not listed on the label) - 80% ABV ethanol and glycerol and hydrogen peroxide added. The product is labelled as gin, however it is not gin, the bottle contains hand sanitiser. The bottles are not correctly sealed, they can be identified as having no shrink wrap seal.
Tandem t:slim X2 Insulin Pump
The pump battery may deplete faster than expected in certain circumstances. Only patients using the pump displaying Dexcom G5 Continuous Glucose Monitor (CGM) values are affected by this issue. If a Transmitter ID is entered incorrectly into the pump, the pump will be unable to connect to the transmitter and will continue to search for that transmitter until the battery charge is depleted or a correct Transmitter ID is entered.
Blackmores Professional Duo Celloids SCF 170 and 84 Tablets
Tablets have been identified as having microbial mould growth ( Penicillium ) appearing on tableted product. This appears to be occurring after some time in storage and is visible to the naked eye as black or brown patchy spots.
MiniMed 640G Insulin Infusion Pump
Certain pumps are missing solder on specific contacts on the Harness Assembly. If the wires make an electrical contact with the Printed Circuit Board Assembly, the lack of solder could result in increased resistance at the connection point, causing early battery depletion. All necessary battery-related alerts/alarms will still occur to inform the user about the AA battery status.
DDU-2000 Series Automated External Defibrillator (AED)
An electrical component may cause the product to abort a shock delivery, or reset unexpectedly.
Inogen One G3 Concentrator
When connected to a fully charged 8-cell battery as its only power source, an operating condition may cause an abrupt shut down of the Inogen One G3 Portable Oxygen Concentrator (POC). If no action is taken, the POC may become unresponsive for up to one minute, after which it will behave as though a battery was just connected with a standard flash screen on display. The POC will then be ready for another startup. If powered on again, this cycle may need to be repeated until the 8-cell battery has been adequately discharged allowing the POC to operate as normal.
Palexia SR 100mg tapentadol (as hydrochloride) sustained release tablets - expanded recall
Blister strips may have faded or missing labelling relating to the batch number or expiry details. The recall is only because of a labelling issue. The quality of the product is not affected.
Stellar 100 and Stellar 150 Portable Ventilators
The audible alarms may not operate properly. Alarms will display on the screen of the Stellar device. Due to a Q64 electronic component failure on the Stellar device, the identified issue is a combination of software and a component failure. The alarm buzzer may not work under the following combined circumstances: 1. The device has a failed Q64 electronic component and, 2. The device is stored without AC power connected for more than 36 hours leading to full depletion of the battery; and, 3. The device powers on automatically when connected to AC power without pressing the power switch.
Brauer Baby & Child Teething Gel (20g)
The recall is due to microbial contamination ( Burkholderia spp ) contamination found through testing samples of this batch.
Accu-Chek Guide and Accu Chek Performa Blood Glucose Meters
The Accu-Chek Guide and Performa blood glucose meters may show the following power-related issues: - Display E-9 Errors (indicating batteries need to be replaced) - Unexpectedly show the low battery icon - Have unexpected short battery life - Not power on Power issues such as those listed may result in a temporary meter unavailability for the user.
Tandem t:slim X2 Insulin Pump AC Wall Power Adapter
The AC power adapters could break apart exposing the metal prongs.
Ellipse Heavy Duty Bariatric Rollator
The thread sleeve that the backrest knob screws into can become loose if over tightened, this could cause the backrest to come off.
Selected Behind-the-Ear Hearing Aids
A software error in the service and repair tool may have altered the specifications for sound amplification, presenting a risk to the user's residual hearing.
Alpha Conducting Solution (ACS) 15mL and Alpha Conducting Solution Replacement (ACSR) 250mL used with Alpha-Stim M and AID Devices
The product may not effectively control microbial contamination. The contamination, if present, will not be readily visible to the naked eye.
Dario Blood Glucose Tracker App Android App Versions 4.3.0-4.3.2
Potential issue with Android App versions of Dario Blood Glucose Tracker (4.3.0-4.3.2), regarding duplicate logging of a blood glucose level reading. The issue may cause blood glucose level readings that are transferred from the measurement screen to the 'Logbook' being replaced by an older blood glucose measurement and being displayed as a duplicate reading.
Various Convex Two-Piece Skin Barriers
On the Convex Two-Piece Skin Barriers, the starter hole (stoma hole) is off-centre.
Jin Gui Shen Qi Wan (Oral Pills)
The product contains levels of aconitum alkaloids that are higher than the limit permitted for a listed medicine. These substances can pose an unacceptable risk to human health. The product label does not restrict the medicine's use to adults.
Hollister Urostomy Bag
There is a possible weakening of the Urostomy bag pouch film.
Endone Oxycodone Hydrochloride 5mg Tablet Blister Pack
A report has been received that a strip of 30mg Anamorph tablets may have been present in a box of 5mg Endone, post dispensing.
Neutrogena Visibly Clear Light Therapy Acne Mask and Activator
Reports of generally mild, rare and transient visual adverse events, and concerns around the safety of blue light on the eyes.
Curam Duo 400/57 Powder for Oral Suspension
During manufacture, the air tight seal in some units may have been compromised. This could allow the entry of moisture from the air.
Fusion Hair Tonic and Oriental Botanicals Hairpro
The products contain Fallopia multiflora , which may cause liver injury in rare cases.
Dang Gui Yin Zi (Tangkuei & Tribulus Combination)
This product does not display the required liver warning on the label: ' Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional.'
Shui An and Yang Xue Sheng Fa Capsules
These products do not display the required liver warning on the label: ' Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional.'
Complementary Medicines containing Fallopia multiflora
These products do not display the required liver warning on the label: 'Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional.' In addition, Fallopia multiflora is an undeclared ingredient for An Shen Ding Zhi Wan
Jurnista Hydromorphone Hydrochloride 8 mg Prolonged Release Tablet Blister Pack
A manufacturing issue with some blister packs has resulted in damage to the outer coating of some tablets.
OA/RA Capsules
A single batch (Batch 17098003) of OA/RA Capsules are being recalled due to contamination with a substance that poses an unacceptable risk to health. This product has also been withdrawn from the Australian market and will no longer be available for supply. TGA testing has found that the currently available batch of the product is contaminated with very low levels of aristolochic acid.
Bronchi-cough Pill (Qiguanyan Kesou Tanchuanwan)
Traces of both Aristolochic Acid and Amygdalin have been found in one batch and only Amygdalin being found in another. This issue does not affect any other batches of Bronchi-cough Pills (Qiguanyan Kesou Tanchuanwan) or any other products supplied by Beijing Tong Ren Tang.
APO-Valsartan 40 mg / 80 mg / 160 mg / 320 mg tablets
Trace amounts of an impurity, N nitrosodiisopropylamine (NDIPA), has been detected in batches of this product.
DILART® and DILART®HCT (Valsartan) Tablets
An impurity, N-nitrosodiethylamine (NDEA) has been found in batches of Valsartan.
Medtronic MiniMed™ 640G Insulin Infusion Pump
The MiniMed 640G Insulin pump with version 4.10 software has failed to make expected audio sounds during alerts, alarms and sirens. The failure could either cause the alarm volume to be stuck at a 4 (out of 5) level regardless of personal settings, or it could make no sound.
LoFric 40cm CH12 Nelaton Catheter
Some urethral catheter boxes have been incorrectly labelled.
Nokia Blood Pressure Monitor Plus
The blood pressure monitor did not pass applicable testing standards for accuracy for subjects with an arm circumference greater than 35cm.
NET Homeopathic Remedies
Potential microbial contamination.
Valpam 5
One batch of Valpam 5 (batch CP218) may contain blister strips with a white Valpam 2mg tablet, instead of a yellow Valpam 5mg tablet.
APO-Metformin XR 1000mg tablets
There has been one report of a small piece of white plastic (likely from a cable/zip tie) being embedded in a tablet from this batch. The plastic may or may not be visible, as it could be completely embedded in the tablet.
Apo-Perindopril Arginine 2.5 mg, 5 mg and 10 mg tablets (bottle) - extended recall (new batches)
It has been identified that some bottles from these batches may be contaminated with dark particles of silica, presumably released from the desiccant cylinder that is placed inside the bottle to keep the contents dry and protected from moisture. The particles may be large enough to see as specks or appear as a dust that discolours the tablets themselves and/or the inside of the bottle.
Gentamicin Injection BP 80 mg in 2 mL Steriluer ampoules in packs of 10 or 50
Potential allergic reaction - affected batches of Gentamicin Injection may contain higher than expected amounts of histamine.
Lucrin Depot Paediatric leuprorelin acetate 30mg for injection, prefilled dual chamber syringe (single dose)
Potential for incomplete delivery of medication. The batch is being recalled due to reports of the active ingredient powder not dissolving sufficiently with the diluent liquid in the syringe, causing clumping. The clumping is readily visible to the naked eye in affected products and should be noticed on inspection.
Lax Sachets
Error in dosage/administration instructions. There is an error in the labelling on the back panel of individual sachets of 4 batches of Lax Sachets with respect to the reconstitution information. The information on the carton and pack insert is correct. INCORRECT LABELLING - Administration: Each sachet should be dissolved in 1 litre of water. CORRECT LABELLING - Administration: Each sachet should be dissolved in 125 mL water. For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.
Medtronic MiniMed Infusion Sets including MiniMed Quick-set, MiniMed mio, MiniMed Silhouette and MiniMed Sure-T (specific lots)
There have been recent reports of potential over-delivery of insulin shortly after an infusion set change. Subsequent investigations have found that this issue may be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol or water is spilled on the top of the reservoir or inside the tubing connector, which could prevent the insulin set from working properly.
Oh Baby! Natural Formula capsules, JO LMax Extra tablets and RUFF Natural Formula 10,000mg capsules
Results of testing by the Therapeutic Goods Administration (TGA) showed that these products contained substances that cannot be supplied without a prescription. Samples of Oh Baby! capsules were tested and found to contain tadalafil. Samples of JO LMax Extra tablets were tested and found to contain dimethylaminoethanol (DMAE or Deanol). Samples of RUFF Natural Formula 10,000mg capsules were tested and found to contain tadalafil, sildenafil and dapoxetine. Dapoxetine, tadalafil, sildenafil and deanol are Prescription Only Medicines in Australia. The supply of any herbal capsules containing undisclosed dapoxetine, tadalafil or sildenafil is illegal. Deanol is a Prescription Only Medicine and while the product was labelled as containing deanol, supply without a valid prescription is also illegal in Australia.
Lignocaine 50 mg/5 mL ampoules
Potential for incorrect product in package. Consumers and health professionals are advised that Pfizer, in consultation with the TGA, is undertaking a recall for product correction of one batch (Batch A313, expiry date Nov 2017) of Lignocaine 50 mg/5 mL ampoules because of the potential for the packaging to contain another product. Users with potentially affected products are asked to inspect their packs to ensure they contain the correct medicine. The recall for product correction was initiated after one NSW consumer being treated with a different Pfizer product, Heparin 5000 IU/5 mL injection 50 pack (Batch A473, expiry date Feb 2019), found the pack contained vials of Lignocaine. The consumer obtained the pack at a community pharmacy. Consumers and health professionals who identify a defective pack should follow the advice below.
Heparin 5000 IU/5mL injection 50 pack ampoules
Potential for incorrect product in package. The recall for product correction was initiated after one NSW consumer being treated with Heparin 5000 IU/5 mL injection 50 pack ampoules, found the pack contained ampoules of a different Pfizer product, Lignocaine 50 mg/5 mL (Batch A313, expiry date Nov 2017). The consumer obtained the pack at a community pharmacy in NSW. Consumers and health professionals who identify a defective pack should follow the advice below.
NovoPen Echo insulin cartridge holder
There is a risk that the cartridge holder may crack or break if exposed to certain cleaning agents.
Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with keyhole clip fastening
The black plastic clip that is attached to the sling by a webbing strap threaded through a slot may break during use.
Elastic Luggage Straps, Assorted Children's Toys and Natural Latex Hot Water Bottles
(a) The elastic luggage straps do not have the required warning label in accordance with Consumer Goods (Elastic luggage straps) Safety Standard 2017. (b) The children’s toys contain batteries that can become accessible through normal use, which does not comply with Consumer Protection Notice No. 14 of 2003, as amended by Consumer Protection No. 1 of 2005. (c) The hot water bottles do not meet the performance, physical and labelling requirements in accordance with the Trade Practices (Consumer Product Safety Standard) (Hot Water Bottles) Regulations 2008.
Valpam 5 (diazepam) 5mg tablets in 50 tablet blister packs
Blister pack sheets containing other medicines may have been substituted into some packs of Valpam 5mg tablets. These medicines may include (but may not be limited to) Amlodipine Sandoz 5mg tablets.
Amlodipine Sandoz 5mg tablets
This medicine may have been dispensed with missing blister sheets.
Stemetil 5mg tablets
This medicine may have been dispensed with missing blister sheets.
Apotex-Pantoprazole 20mg Tablets
This medicine may have been dispensed with missing blister sheets.
Apotex-Pantoprazole 40mg tablets
This medicine may have been dispensed with missing blister sheets.
BTC Rosuvastatin 10mg tablets
This medicine may have been dispensed with missing blister sheets.
BTC Paracetamol Codeine tablets
This medicine may have been dispensed with missing blister sheets.
Valium (diazepam) 5mg tablets in 50 tablet blister packs
Blister pack sheets containing other medicines may have been substituted into some packs of Valium 5mg tablets. These medicines may include (but may not be limited to) BTC Paracetamol Codeine, BTC Rosuvastatin 10mg tablets, Apotex-Pantoprazole 40mg or 20mg tablets and Stemetil 5mg tablets.
Hylands Baby Teething Tablets and Nighttime Teething Tablets
The products contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products' labels.
Span-K (potassium chloride) 600mg tablets
This is a recall for correction of the packaging only. The bottles have been supplied with a cap that is not child-resistant. There is no concern regarding the quality or safety of this medicine.
EPIPEN 300 microgram (µg) Adrenaline Injection Syringe Auto-Injector (AUST R 42978)
There is a potential that these devices may contain a defective part that may result in the device failing to activate or requiring increased force to activate.
Difflam Sore Throat Ready to Use Iodine Gargle
An out-of-specification (OOS) result has been recorded for povidone-iodine assay in one batch of the Difflam Sore Throat Ready to Use Iodine Gargle (povidone-iodine 10mg/mL) 200mL bottle. The OOS result for povidone-iodine assay occurs early in the product's shelf-life (2 months).
Medtronic MiniMed 640G insulin pumps
Medtronic has identified a software issue that could prevent the internal battery from charging on some MiniMed 640G insulin pumps. If the issue occurs, an alarm is triggered and patients will see "Power error detected" and "25" displayed on the pump screen (power error 25). The message states "Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See User Guide."
Biolo World Slimming Capsules
Product contains undeclared substances sibutramine and phenolphthalein.
O2Vent T Adjuster Assembly
The manufacturer has determined that a correction to the Adjuster Assembly part of the O2Vent T device is necessary and must be returned for rework. The Adjuster Assembly allows adjustment of the screw and hook for appropriate titration by mandibular advancement for optimised treatment.
Sleep-Safe Set, Sleep-Safe Set Plus and Sleep-Safe Paed
The products may experience leakage caused by over welded coils, which can lead to difficulties in unrolling the tubing that can create pinholes in the lines. The damage may not be visible and will not be detected by the system's Sleep-Safe cycler.
O2Vent T Instructions for Use
A correction to the Instructions for Use in relation to the adjustment range for titration is necessary.
Chinese Sports Injuries Pill (Zhong Guo Die Da Wan)
Testing of products from the affected batch has detected the presence of very low levels of aristolochic acid.
Dilantin (phenytoin sodium) 30 & 100mg capsule bottles and Dilantin (phenytoin) Infatabs 50mg tablet bottle
It has been identified that bottles of Dilantin have been supplied with child-resistant caps that may not engage or otherwise be properly secured.
Deluxe First Aid Kit
The first aid instructions supplied are poorly written and cannot be relied upon in an emergency. Some of the information is unsuitable and not in line with Australian first aid protocols.
Du Huo Ji Sheng Tang (Tuhuo and Loranthus Combination), Chuan Xiong Cha Tiao San (Ligusticum and Tea Formula) and Dang Gui Si Ni Tang (Tangkuei and Jujube Combination)
The products contain Asarum species, which have been documented to contain aristolochic acids. Asarum species containing aristolochic acid(s) for human therapeutic use are included in Schedule 10 of the Poisons Standard and are not permitted for use in therapeutic goods in Australia.
Metagenics Nasoclear Nasal Spray 30mL
Some products from the affected batch may contain a pathogenic organism, Staphylococcus aureus , commonly known as golden staph.
Various Comfort impregnated cloth topical skin products
Some batches of the products are contaminated with the bacteria Burkholderia cepacia .
APO-Cabergoline 500mcg tablets
Apotex Pty Ltd is recalling one batch of the APO-Cabergoline 500mcg tablets (batch MK0903, expiry date February 2017) due to a packaging issue, where the desiccant may not protect the product from moisture throughout its shelf life.
GlucaGen HypoKit Glucagon (rys)
Possibility of injection needle detaching from 1mL pre-filled solvent syringe.
Flocare Infinity Enteral Feeding Pumps
Nutricia Australia has received overseas reports of the Flocare Infinity enteral feeding pump 'air in line' (AIL) alarm not always working when used with mixed or reconstituted powdered tube feeds. It is believed that undissolved particles can accumulate in the feeding line or form a film on the inner side of the tube around the pump sensors, which can interfere with the pump's air detection function.
Detachable wall plug for AC power adapter for Medela Swing, Swing Maxi, Swing Essentials, Swing Premium and Freestyle Breastpumps
The detachable wall plug could split, exposing a live metallic contact.
Astral 100 and Astral 150 ventilators
ResMed has received a number of reports regarding the performance of the internal battery in Astral 100 and Astral 150 ventilators. According to these reports, an internal electrical issue has led to ventilation stopping without either the 'low battery' or 'critically low battery' alarms activating as intended.
EN1223S Water-Resistant Pendants & EN1233S Single Button Pendants
Incorrect programming means that the products are not operating as intended and the affected pendant products will be unable to send an alarm upon activation of the button press mechanism; therefore cannot elicit a response from a designated responder.
James Leckey Design Mygo Stander
The angle adjustment mechanism for James Leckey Design Mygo Standers manufactured during this period allows the user to lock out the frame’s safety pull pin and adjust the angle using one hand. If the operator’s hand slips off the turning handle when a patient is in the frame, the handle could ‘self-wind’ and spin rapidly as the stander returns to the upright position.
Military Trauma and Haemorrhage Wound Dressing
It has been identified that the pressure bar material in the affected batch may break during use.
TRUEresult Blood Glucose Test Strip
It has been identified that some of the test strips from the affected batch may have been contained within an open test strip vial. Being exposed to the outside environment can affect test strip performance and lead to false low readings.
Children’s Panadol 5-12 Suspension (Strawberry and Orange) 200mL
There is a possibility of a small quantity of particulate contamination in an ingredient that is used to manufacture the products listed above.
Dexcom Continuous Glucose Monitor Receivers
There is a possibility that the audible alarms may not work.
Betamin 100 mg vitamin B1 tablets
The recall is due to the potential that some bottles may contain at least one Plavix/Iscover (clopidogrel 75 mg) tablet.
Mums The One One Step hCG Urine Pregnancy Test
TGA testing of Mums The One one step hCG urine pregnancy tests from the affected batch found that these tests do not meet a claim made in the product documentation. Specifically, these tests failed to detect hCG at concentrations of 10 mIU/mL, 25 mIU/mL and 50 mIU/mL levels.
SHEN NENG CHING FEI YI HOU PIEN (AUSTL 57184)
SHEN NENG CHING FEI YI HOU PIEN (AUSTL 57184) was found by TGA Laboratories to be contaminated with Paracetamol. The content of paracetamol was estimated by LC/MS to be 9 mcg/g (9 ppm). This is below the SUSMP threshold limit of 10 ppm (10 mg/kg) for scheduling of paracetamol. However, paracetamol is not declared in the ARTG entry for AUSTL 57184 and is not approved for use in listed medicines.
ConceivePlease One Step HCG Urine Pregnancy test
TGA testing of ConceivePlease one step hCG urine pregnancy test kits from the affected batch found that these kits do not meet a claim made in the product documentation. Specifically, these tests failed to detect hCG at concentrations of 25 mIU/mL levels.
Maxagra Capsules
The Therapeutic Goods Administration (TGA) has tested a product labelled Maxagra capsules and found that: •the capsules contain the undeclared substance sildenafil; and •the capsules contain the undeclared antibiotic substance oxytetracycline
Veletri Consumables Kit
It has been identified that B. Braun water for injections from this lot may leak due to cracks in the neck of the bottle, which could result in bacterial contamination.
Raw Meal Organic Shake & Meal Replacement, Raw Meal Chocolate Organic Shake & Meal Replacement, Raw Meal Vanilla Organic Shake & Meal Replacement
The recall is due to a Microbial (Salmonella) contamination.
Forever Young Diet Supplement
The recall is due to the presence of an undeclared allergen (fish).
Flocare Transition Giving Sets
There have been reports of ENFit transition adaptors, which are supplied in Australia as a component of Flocare transition giving sets, leaking and/or breaking.
HeartWare Ventricular Assist Device AC adapters and batteries
Some of HeartWare's AC adapters are vulnerable to power grid surges above 220 volts and, when affected, will automatically switch to a back-up power source (batteries). In addition, some HeartWare batteries supplied before December 2014 have the potential to lose their charge prematurely.
Amcal children's paracetamol elixir for 1 to 5 years, Amcal children's paracetamol suspension for 6 to 12 years, Amcal ibuprofen suspension for children, and Amcal cetirizine oral solution
There is a risk of the bottle grooves breaking off when opening the bottle.
Guardian children's paracetamol elixir for 1 to 5 years
There is a risk of the bottle grooves breaking off when opening the bottle.
Pharmacy Care ibuprofen suspension for children and Pharmacy Care cetirizine oral solution
There is a risk of the bottle grooves breaking off when opening the bottle.
Amcal Children's Paracetamol, Elixir & Guardian Paracetamol Elixir
There is a risk of the bottle grooves breaking off when opening the bottle.
Amcal & Pharmacy Care Cetirizine
There is a risk of the bottle grooves breaking off when opening the bottle.
Amcal & Pharmacy Care Ibuprofen Suspension
There is a risk of the bottle grooves breaking off when opening the bottle.
Children’s paracetamol 1 to 5 years & 6 to 12 years and children’s ibuprofen for 6 months to 12 years
It has been identified that the bottle grooves that secure the lids on these products could break off during opening.
200mL children’s paracetamol syrup for 1 to 5 years & 6 to 12 years
It has been identified that the bottle grooves that secure the lids on these products could break off during opening.
Various Products
The presence of an undeclared allergen (dairy).
APO-Paracetamol 500mg Tablets
Tablets could contain small pieces of latex.
Pharmacy Care Children's Paracetamol Elixir for 1 to 5 years and Pharmacy Care Children's Paracetamol suspension for 6 to 12 years
There is a risk of the bottle grooves breaking off when opening the bottle.
Pharmacy Choice Children's Paracetamol 6 to 12 Years Concentrated & Pharmacy Choice Ibuprofen Children's Suspension
There is a risk of the bottle grooves breaking off when opening the bottle.
Terry White Chemists Ibuprofen Children's Suspension
There is a risk of the bottle grooves breaking off when opening the bottle.
Pharmacy Choice Ibuprofen Children's Suspension
There is a risk of the bottle grooves breaking off when opening the bottle.
Chemmart Ibuprofen Children's Suspension
There is a risk of the bottle grooves breaking off when opening the bottle.
Chemmart Children's Paracetamol 6 to 12 years concentrated
There is a risk of the bottle grooves breaking off when opening the bottle.
Invacare Platinum Oxygen Concentrator
Due to a potentially faulty component in some units, the compressor motor start-run capacitor may rupture.
Dostinex, Cabaser and Methoblastin
The products have been supplied in containers without child-resistant closures. Please note that there is no concern regarding the quality or safety of this medicine other than the absence of child resistant packaging.
Halcion, Ponstan and Xanax
The products have been supplied in containers without child-resistant closures. Please note that there is no concern regarding the quality or safety of this medicine other than the absence of child resistant packaging.
2014 Hot Water Bottles
When misused the hot water bottle may split causing burns.
SKYLA Electric Hot Pack
Bladder may rupture and cause scalding.
Neck Cushion and Cover
The zip on the product does not have a child-resistant slide fastener, and the product does not have the required warning label.
Hot Water Bottles
The hot water bottles do not have the required safety warning permanently marked on them as per Trade Practices (Consumer Product Safety Standard) (Hot Water Bottles) Regulation 2008.
Accu-Chek Spirit Combo Insulin Pump
In a small percentage of Accu-Chek Spirit Combo insulin pumps, a faulty component in the vibration alarm may generate an error message ('E7: ELECTRONIC ERROR') and an audible signal at pump start up. If this occurs, it will prevent the pump from operating.
Accu-Chek Mobile Blood Glucose Meter
It has been identified that a small number of Accu-Chek Mobile blood glucose meters have given incorrect high blood glucose readings as a result of the user not following the device instructions. Improper handling can include using the meter with unclean hands, pressing the finger too hard and too long on the test field or smearing the blood while performing a test.
Dexaprine XR Green Apple Supplement Powder
The recall is due to the presence of prescription only medications, including oxedrine and high levels of caffeine.
Accu-Chek Mobile
It has been identified that the antibiotic ceftriaxone can interfere with the way the measurement is made and may lead to incorrectly low blood glucose readings. Ceftriaxone is a broad-spectrum antibiotic used to treat a wide variety of common infections.
Bayer Canesten Clotrimazole Thrush Treatment 6 Day Cream 35g AUST R 18699
The plastic applicator used in the affected batches may have a production problem resulting in extruding plastic at the opening or visible signs of black marks or spots.
Chrysotile Healing Crystals
Recent testing has detected the presence of chrysotile asbestos (white asbestos) in the crystals. The importation of asbestos or goods containing asbestos into Australia is restricted under the Customs (Prohibited Imports) Regulations 1956 (Customs Prohibited Import Regulations).
Children's Panadol 1-5 Years Suspension
The higher levels of paracetamol in the two affected batches may result in doses that are over the recommended and labelled doses but not to the extent that they pose risks to children when the product is used according to the directions on the label.
Children's Panadol Syringe
The syringe may display incorrect dosage indicators.
Woolworths Homebrand Cotton Tips (200 Pack)
Woolworths is recalling this product due to a potential safety hazard, as the cotton can readily detach and become lodged deep within the ear and may require medical treatment to remove it. The product is being recalled as a precautionary measure to minimize this risk.