Alerts

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

Shortage of abatacept (Orencia) medicines - update and information

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

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

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

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

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

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

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.

Philips Respironics patient interface devices (face and nasal masks) with magnetic clips - New warnings

This page contains the original recall in June 2021 and progress updates to mid-2022.

Update on BiPAP settings issues and recall progress

Breast implants (all alerts)

On 8 September 2022, the US Food and Drug Administration issued a safety communication about reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants.

Safety advisory - low levels of contamination with a nitrosamine impurity

The TGA received advice about high levels of lead and other heavy metals in the Ayervedic medicine named Penisole.

TRIKAFTA tablets may be incorrectly located in their pack (wallets).