Alerts

Health professionals and consumers are advised that Medtronic Australasia is issuing a hazard alert for its Consulta Cardiac Resynchronization Therapy Pacemaker (CRT-P).

Health professionals and consumers are advised that GE Healthcare, in consultation with the TGA, has initiated a recall for product correction for a number of its nuclear medicine imaging systems.

B. Braun Australia is withdrawing the cementless version of the Columbus Knee System from the Australian Register of Therapeutic Goods (ARTG). They have also issued a related hazard alert to surgeons.

Synthes Australia, in consultation with the TGA, is recalling unused stock of its 3.7 mm and 5.0 mm Dynamic Locking Screws.

Consumers and health professionals are advised that Medtronic, in consultation with the TGA, has initiated a recall for product correction for its Medtronic Paradigm insulin infusion sets.

Johnson & Johnson Medical has initiated a recall of all unused stock and issued a hazard alert to implanting surgeons for two Codman Certas Programmable Valve products.

Health professionals and consumers are advised that Roche Diagnostics Australia, after consultation with the TGA, has initiated a recall for product correction for its CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro INR monitors.

Health professionals and consumers are advised that Abbott Diabetes Care, after consultation with the TGA, has initiated a recall for product correction for its FreeStyle InsuLinx Blood Glucose Meter.

Health professionals and consumers are advised that Alcon Laboratories Australia, in consultation with the TGA, has issued a hazard alert regarding AcrySof Cachet Phakic Lenses.

Health professionals and consumers are advised that Johnson & Johnson Medical Pty Ltd, after consultation with the TGA, is recalling its OneTouch Verio IQ Blood Glucose Meter.

Health professionals and consumers are advised that Hoya Surgical Optics, in consultation with the TGA, is recalling certain Hoya One-Piece Intraocular Lenses (IOLs) that are in the supply chain.

Health professionals and patients are advised that a review of post-market surveillance data has identified that the Adept 12/14 Modular Head has a higher than expected revision rate.

Health professionals and consumers are advised that sponsor, Sorin Group Australia, in consultation with the TGA, has issued a hazard alert for Isoline defibrillation leads.

Precautionary product notification for GlaxoSmithKline Australia (GSK) influenza vaccine, Fluarix

Updated information regarding patient follow-up for the ABGII Modular Femoral Stem and Modular Neck hip replacement system

Poly Implant Prothèse (PIP) update

The TGA has performed and reported on a large number of tests on the chemical properties, physical properties and the biological safety of the gels and shells of PIP breast implants.

PIP breast implants: Consumer questions & answers

GlaxoSmithKline (GSK) and Alphapharm, in consultation with the TGA, are undertaking a voluntary recall of several batches of Ventolin and Asmol inhalers due to a fault in the delivery mechanism of a small number of inhalers within each batch. This can lead to less than the full dose being delivered for each puff.

Poly Implant Prothèse (PIP) update