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FDA (Device enforcement)Recalled 2024-08-07class ii

Cook Biotech, Inc.: Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614

Hazard

Products expire prior to the expiration date printed on the product labeling

Details from the source

Reason for recall: Products expire prior to the expiration date printed on the product labeling Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom. Quantity: 102 units Lot/code info: UDI: (01)00827002546141(17) Lot Number: LB1524449 LB1524454 LB1524460 LB1524465 LB1524482 LB1526801 LB1526803 LB1526900 LB1528808 LB1528812 LB1529886 LB1529893 LB1530966 LB1530984 LB1533320 LB1533329 LB1534893 LB1534902 LB1537013 LB1537052 LB1537834 LB1537846

UPC codes

00827002546141

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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