Alerts

Update - Suspended breast implant devices now cancelled

Philips has advised that corrected pads will be shipped in early 2023 to customers affected by the problem.

The shortages list of antibiotics has been updated.

Recall of Glute Master -Maxx Products

Joint statement on the Ozempic (semaglutide) shortage and prioritisation for people with type 2 diabetes.

A reminder for health professionals and consumers on safe and equitable dispensing and supply

Recall of API Forearm crutches - tall and adult sizes

Philips Respironics (the manufacturer) detected two problems with corrected Trilogy 100 ventilators

Zimmer Biomet, in consultation with the TGA, is issuing an Implant Hazard Alert for the NexGen Stemmed Cemented Option Tibial Component.

To assist with timely access for patients using cefalexin, the TGA has made a Serious Scarcity Substitution Instrument (SSSI).

The SSSI for isosorbide mononitrate 120mg modified release tablets is extended to 30 June 2023.

Safety advisory - Compatibility of tubing connectors and medical gas sources

Safety advisory - contamination of quinapril medicines with low levels of nitrosamine impurity

Statement on the post-market review of heater-coolers including updated table of heater-coolers.

To assist with timely access for patients using amoxicillin, the TGA has made a Serious Scarcity Substitution Instrument (SSSI).

Aidacare Pty Ltd - Aspire Superlite Adjustable Seat Walker - Consumer Level Product Defect Correction - Securing nut incorrectly assembled

Safety alert relating to CPAP and BiPAP face and nasal masks that contain magnets which may cause active implantable devices to malfunction

The list of current ARTG entries for breast implants has been updated

Recall of one batch of Vicks VapoRub Xtra Strong 100g (AUST L 372739) which has been incorrectly labelled as Vicks Vaporub ointment

Product Defect Alert - Unclear instructions may result in overdose of boron

Extension of SSSI for abatacept (Orencia)

Insulet Australia Pty Ltd has received reports of problems with the Omnipod DASH Personal Diabetes Manager (PDM). These include battery swelling, fluid leaking from the battery and in rare cases, extreme overheating which may pose a fire hazard.

Update on Trilogy 100 Ventilators

BEWARE - Health supplements containing vitamin B6 can cause peripheral neuropathy

Recall of JSHealth Vitamins listed medicine Detox + Debloat.