Showing notices 49–96 of 227.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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).
Pharmacy and medical productsThe 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)
Pharmacy and medical productsThe product contains Carthamus tinctorius flower (safflower flower) extract, as an inactive ingredient, but does not include the required pregnancy warning label.
Pharmacy and medical productsThe affected batches are contaminated with a low level of Burkholderia cepacia bacteria.
Pharmacy and medical productsCertain 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.
Pharmacy and medical productsWipes 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.
Pharmacy and medical productsNimbus 4 and Nimbus Professional mattresses may over-inflate, due to an inner mattress component failure. This cannot be detected until the product is disassembled.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe products were supplied in the Australian market without an Australian Registry for Therapeutic Goods (ARTG) registration and were also labelled to contain Acorus calamus .
Pharmacy and medical productsIn 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.
Pharmacy and medical productsA 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).
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsIf 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.
Pharmacy and medical productsPotential 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.
Pharmacy and medical productsWhen used at high doses or for prolonged periods, the product can expose children to higher than safe levels of chloroform.
Pharmacy and medical productsThe mains cables may become damaged through incorrect stowage or misuse.
Pharmacy and medical productsThere 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.
Pharmacy and medical productsA 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.
Pharmacy and medical productsThe product contains less than the 70% or 75% alcohol content that is detailed on the product's label.
Pharmacy and medical productsFollowing 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.
Pharmacy and medical productsThe pump of the affected units may malfunction resulting in low suction levels or failure to provide suction.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsSome products have been released without a statement on the label identifying that the product contains Manuka Honey.
Pharmacy and medical productsSome 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.
Pharmacy and medical productsRecall due to the visual presence of black spots resembling mould growth. No other batches of Aerowipe Cleansing Wipes are affected by this recall.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsConsumers 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.
Pharmacy and medical productsIf the backup batteries have been depleted and a fire occurs during power loss, the Flash Receiver will not produce an alert.
Pharmacy and medical productsA 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsThe 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.
Pharmacy and medical productsReports 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.
Pharmacy and medical productsThe 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.