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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00161-1
Product Name/Description	Chiba Biopsy Needle Reference part number (RPN): DCHN-22-20.0-U Order number (GPN): G04338 Lot number: NS15808547 ARTG 138559 (William A Cook Australia Pty Ltd - Biopsy Access Needle - Needle, aspirating, single use)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	28/02/2024
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical 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. Cook Medical has not received any customer complaints related to the adverse patient effects listed above for the affected lot. However, compromised device sterility may go undetected by the user.
Recall Action	Recall
Recall Action Instructions	Customers must examine their inventory immediately for affected products, quarantine and cease use and return them to Cook Medical.
Contact Information	1800 777 222 - Cook Medical Customer Relations