Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Cook Incorporated Approach Micro Wire Guide Devices Hydro ST Microwire Wire Guide & CTO Microwire Wire Guide [Ref part #: HMW-14-190-ST, CMW-14-300-18G] [HKMD No.: 110495].
According to the TGA, the manufacturer has identified that devices from the affected lots have labels that state the incorrect expiration dates.
During a review of label prints, lots with labels stating incorrect expiration dates were detected due to a calculation error in Cook’s labelling software, which uses a calculator to determine the correct expiration date. The calculator assigned the maximum potential shelf life to lots in scope rather than the actual shelf life.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00867-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 08 Oct 2024