FDA-Device2024-07-24Class II
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Ethicon Sarl, a Johnson & Johnson Company
Hazard
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Sold states
Worldwide distribution - US Nationwide and the countries of India and Japan.
Affected count
450,793 units (65,950 US, 384,843 OUS)
Manufactured in
rue du Puits-Godet 20, Neuchatel, Switzerland
Products
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2406-2024Don't want to check this manually?
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