Alerts

Specific lots of Other-Sonic Generic Ultrasound Transmission Gel have been recalled due to contamination by bacteria.

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Endeavour Industries is recalling this walking stick because it has been manufactured using a grade or gauge of aluminium tube which is inadequate.

Endeavour Industries brand Quad (4 X Point) Walking Sticks, Product Code X640, are being recalled.

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

CSL Biotherapies is recalling the batch 3450700309 of Albumex 4, due to the presence of ethylene glycol

MITCH TRH Modular Head (used in hip replacements) - product cancellation

Poly Implant Prothèse (PIP) update

The TGA advises patients and health care professionals of problems with the battery life in some EnTrust ICD D154ATG and EnTrust ICD D154VRC implantable cardiac defibrillators (ICDs).

Poly Implant Prothèse (PIP) update

Poly Implant Prothèse (PIP) update

On 21 March 2012, the TGA agreed that the release procedure involving TGA's batch-by-batch review of CSL's ethylene glycol test results need not apply to batches of albumin solution manufactured after 25 January 2012.

PIP breast implants are known to have been used in Australia from September 1999 until April 2010, when non-implanted PIP breast implants were recalled from the market following advice from the French regulator (AFSSAPS) that in making these devices the manufacturer had used unapproved materials which may affect their safety and performance.

PIP breast implants are known to have been used in Australia from September 1999 until April 2010, when non-implanted PIP breast implants were recalled from the market following advice from the French regulator (AFSSAPS) that the manufacturer had used unapproved materials in making these devices which may affect their safety and performance.

Australia's medical devices regulator, the Therapeutic Goods Administration (TGA) again encourages women who have had breast prostheses implanted since 1998 to contact their surgeon to find out the brand of their implant and to attend for a check-up if they know or suspect they have an implant made by the French company Poly Implant Prothese (PIP).

Quarantine of some CSL Biotherapies batches of human albumin product (ALBUMEX) pending further analysis

CSL Biotherapies notified the TGA on 7 March 2012 that some batches of human albumin solutions manufactured prior to 25 January 2012 have been contaminated with ethylene glycol as a consequence of an equipment failure.

As an important part of its regulatory activities, the TGA strongly encourages reports of problems with medical devices to help identify safety concerns.

Some batches of Albumex manufactured prior to 25 January 2012 may be contaminated with very low levels of ethylene glycol