Ethicon Sarl, a Johnson & Johnson Company recalls SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
- Recall date
- June 11, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2406-2024
- FDA classification
- Class II
- Brand / firm
- Ethicon Sarl, a Johnson & Johnson Company
- Sold / distributed
- Worldwide distribution - US Nationwide and the countries of India and Japan.
Why it was recalled
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
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