Class II
Medical Device Recall: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Ethicon Sarl, a Johnson & Johnson Company · June 11, 2024
Reason for Recall
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Distribution
Worldwide distribution - US Nationwide and the countries of India and Japan.
States Affected
NATIONWIDE
Quantity Affected
39,010 units (All US)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2407-2024
Status: ongoing
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