Alerts

The Therapeutic Goods Administration (TGA) has been advised by Ferno Australia Pty Ltd that a small number of Meducore Easy Automatic External Defibrillator (AEDs) that are currently being recalled for product correction cannot be located.

The TGA has become aware that the EIUS unicompartmental1 knee prosthesis supplied by Stryker Australia has a higher than expected revision rate (rate of revision surgery). Supply of the product in Australia has been suspended.

This is an update to the alert issued by the TGA on 16 June 2011. Johnson and Johnson have advised the TGA of additional serial numbers affected by the recall.

Specific packs of Avaira Toric contact lenses are being recalled by CooperVision Australia Pty Ltd

The Therapeutic Goods Administration (TGA) has been advised that TRIAD Sterile Lubricating Jelly, 3g sachet, with lot numbers beginning with 7, 8, 9 or 0, is being recalled as it may not have been properly sterilised.

Recall of IGC Dorel Safety 1st Complete Healthcare Kit: Thermometer

Concerns have been expressed that a range of breast screening devices based on technologies other than mammography have not been appropriately assessed for their safety or accuracy.

On 26 January 2011, the US Food and Drug Administration (FDA) announced a safety communication to warn about an association between breast implants and anaplastic large cell lymphoma. The risk of a patient developing this type of lymphoma is very low.

About Brachytherapy kits (regulatory status)

The Therapeutic Goods Administration (TGA) has received enquiries about the recall of the LCS® DuofixTM Femoral Knee Replacement Component.

The TGA is aware that the French authorities have now released an updated statement in regard to the testing of the PIP implants:

Testing on Australian Poly Implant Prothèse (PIP) samples of implants has been undertaken by TGA

Continuing investigation into issues with Poly Implant Prothèse (PIP) silicone gel-filled breast implants

Medical Visions Australia Pty Ltd following consultation with the Therapeutic Goods Administration is undertaking the recall of all non implanted silicone gel breast implants manufactured by Poly Implant Prothèse (PIP). The recall applies to all models of this type of implant.

In October 2009 an anaphylactic reaction to the Panvax H1N1 pandemic influenza vaccine was reported in Western Australia in a person known to have a pre-existing latex allergy.

A number of brands of hot/cold gel packs are being recalled following testing by the Therapeutic Goods Administration (TGA) of contents for ethylene glycol, a toxic substance. Testing was undertaken following the previous recall of Thermoskin® hot/cold gel packs to determine if the problem was more widespread.