Z-2407-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2024
- Initiation Date
- June 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39,010 units (All US)
Product Description
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Reason for Recall
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of India and Japan.
Code Information
Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers: