Surgicel Fibrillar 1inx2in(2.5cmx5.1cm) recall: Sterility Concern
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Why was Surgicel Fibrillar 1inx2in(2.5cmx5.1cm) recalled?
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:
- Product
- SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
- Recalling firm
- Ethicon Sarl, a Johnson & Johnson Company
- Quantity
- 39,010 units (All US)
- Distribution
- Worldwide distribution - US Nationwide and the countries of India and Japan.
- Recall date
- July 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)