Alerts

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

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

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

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.

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).

The TGA is investigating potential contamination of quinapril medicines with low levels of nitrosamine impurity

The TGA has become aware of instances where patients have become falsely reassured by the home use fetal dopplers and delayed medical attention.

Microbial contamination in several batches of Lucas' Papaw Ointment

MiniMed 600 and 700 series Insulin Pumps - Medtronic - Loss of power due to cracked or damaged battery cap.

Medtronic Cobalt and Crome ICDs and CRT-Ds - software update required

HERO Instant Energy for Male products pose a serious risk to your health and should not be taken

Human albumin (all alerts)

Product Defect Correction - Software errors affecting battery life and insulin delivery

Swisse Beauty Collagen Glow Gummies - Recall due to potential mould

Updated list of various sunscreens containing Cancer causing chemical Benzene - Recalls due to detection of Benzene.

KYND Stress Relief tablets - Recall due to unexpected number of allergic reactions