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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01040-1
Product Name/Description HeartWare Sterile Surgical Tool Sets (Supplied as part of the HeartWare Ventricular Assist System, artifical heart (HVAS))

Catalogue Number: 1318

Lot Number: 520863

ARTG Number: 181875
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 31/10/2012
Responsible Entity Heartware Pty Limited
Reason/Issue There is an error with labelling regarding the “Use by Date” of Sterile Surgical Tool products (ref. Cat # 1318). More specifically, some units were labelled with a “Use by Date” corresponding to 2-years shelf life instead of the approved 1-year shelf life.
Recall Action Recall
Recall Action Instructions The sponsor is advising users of changes to the approved use by date and is asking users to inspect current inventory and amend the use by dates of affected products.
Contact Information 02 8078 6164 - Heartware