FDAFDA · Food and drugs·Recall number Z-2407-2024
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Published July 24, 2024 · Recall initiated: June 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon Sarl, a Johnson & Johnson Company
- Distributor
- Worldwide distribution - US Nationwide and the countries of India and Japan.
- Lot
- Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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