227 archived Australian notices, each linked to its official Product Safety Australia source. The page updates automatically when new notices arrive.
Showing notices 97–144 of 227.
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.
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.
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.
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.
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.
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.
An electrical component may cause the product to abort a shock delivery, or reset unexpectedly.
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.
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.
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.
The recall is due to microbial contamination ( Burkholderia spp ) contamination found through testing samples of this batch.
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.
The AC power adapters could break apart exposing the metal prongs.
The thread sleeve that the backrest knob screws into can become loose if over tightened, this could cause the backrest to come off.
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.
The product may not effectively control microbial contamination. The contamination, if present, will not be readily visible to the naked eye.
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.
On the Convex Two-Piece Skin Barriers, the starter hole (stoma hole) is off-centre.
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.
There is a possible weakening of the Urostomy bag pouch film.
A report has been received that a strip of 30mg Anamorph tablets may have been present in a box of 5mg Endone, post dispensing.
Reports of generally mild, rare and transient visual adverse events, and concerns around the safety of blue light on the eyes.
During manufacture, the air tight seal in some units may have been compromised. This could allow the entry of moisture from the air.
The products contain Fallopia multiflora , which may cause liver injury in rare cases.
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.'
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.'
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
A manufacturing issue with some blister packs has resulted in damage to the outer coating of some tablets.
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.
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.
Trace amounts of an impurity, N nitrosodiisopropylamine (NDIPA), has been detected in batches of this product.
An impurity, N-nitrosodiethylamine (NDEA) has been found in batches of Valsartan.
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.
Some urethral catheter boxes have been incorrectly labelled.
The blood pressure monitor did not pass applicable testing standards for accuracy for subjects with an arm circumference greater than 35cm.
Potential microbial contamination.
One batch of Valpam 5 (batch CP218) may contain blister strips with a white Valpam 2mg tablet, instead of a yellow Valpam 5mg tablet.
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.
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.
Potential allergic reaction - affected batches of Gentamicin Injection may contain higher than expected amounts of histamine.
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.
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.
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.
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.
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.
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.
There is a risk that the cartridge holder may crack or break if exposed to certain cleaning agents.
The black plastic clip that is attached to the sling by a webbing strap threaded through a slot may break during use.