FDA Enforcement
Class II
Ongoing
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Recall: Z-2407-2024
·
Reported July 24, 2024
Enforcement
- Recall Number
- Z-2407-2024
- Event ID
- 94831
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ethicon Sarl, a Johnson & Johnson Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 24, 2024
- Initiation Date
- June 11, 2024
- Classification Date
- July 17, 2024
- Address
- rue du Puits-Godet 20, Neuchatel, N/A, Switzerland
Description
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Reason
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Code Info
Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:
Distribution
Worldwide distribution - US Nationwide and the countries of India and Japan.
Quantity
39,010 units (All US)