Alerts

Recall - potential for particulate contamination

Hazard alert due to devices no longer be used to treat migraine.

Hazard alert - potential for temporary malfunction during automated testing

Hazard alert - potential for valve to move after implantation.

Recall - may contain incorrect gel

Hazard alert due to potential for component fracture.

Consumers and health professionals are advised that Roche Diagnostic Australia, in consultation with the TGA, has initiated a recall for product correction for its Accu-Chek Spirit Combo insulin pumps.

Recall - potential for particulate contamination

Alcon Laboratories Australia, in consultation with the TGA, has issued a hazard alert regarding AcrySof Cachet phakic lenses and has withdrawn the lenses from the market.

Boston Scientific, in consultation with the TGA, has issued a hazard alert to cardiologists and surgeons regarding some models of Cognis Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Teligen Implantable Cardioverter Defibrillators (ICDs).

Wright Medical Australia has issued a hazard alert regarding specific lots of its Claw and Claw II plates. Wright Medical Australia is also recalling unused stocks of the affected lots.

St Jude Medical, in consultation with the TGA, has issued a hazard alert regarding a potential issue with its Ellipse family of implantable cardioverter defibrillators (ICDs).

Johnson & Johnson Medical, in consultation with the TGA, has issued a hazard alert for two Codman Certas Programmable Valve products.

Hazard alert due to faulty threads potentially preventing installation of drop-down stem extension or stem plug.

Global Orthopaedic Technology is issuing a hazard alert for the MSA Hip System due to it having a higher-than-expected revision rate.

Recall due to potential for delay to treatment in rare cases.

Consumers and health professionals are advised that Roche Diagnostic Australia, in consultation with the TGA, is undertaking a recall for product correction of its Accu-Chek Mobile blood glucose meter due to the potential for incorrect blood glucose readings as a result of users not following the device instructions.

The TGA has suspended the Cereform silicone gel-filled breast implants and associated sizers from the Australian Register of Therapeutic Goods.

Invacare Australia, in consultation with the TGA, is undertaking a recall for product correction of some units of its Aquatec Ocean VIP mobile shower and toilet commode.

Recall due to potential for connection issues.

Synthes Australia, in consultation with the TGA, is issuing a hazard alert for its BC Distractor Body, a component of the Craniomaxillofacial (CMF) Distraction System.

Recall for product correction due to potential for front wheels to break.

Consumers and health professionals are advised that Pfizer Australia, in consultation with the TGA, is recalling one batch of its Xyntha 500IU dual-chamber syringe.

Consumers and health professionals are advised that Roche Diabetes Care, in consultation with the TGA, is undertaking a recall for product correction of its Accu-Chek Mobile glucose tests due to the potential for a commonly used antibiotic to interfere with blood glucose test results.