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 Chiba Biopsy Needle [Reference part number (RPN): DCHN-22-20.0-U; Lot number: NS15808547] [HKMD number: 120288].
According to the TGA, the manufacturer is recalling a specific lot (NS15808547) of Chiba Biopsy Needles. The affected lot may have packaging seals that do not meet peel strength specifications.
This creates a potential of a sterile barrier failure that could result in compromised device sterility.
Potential adverse events include increased procedural time and infection, potentially being life-threatening and/or requiring medical/surgical intervention.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00161-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Mar 2024