Cook Biotech recalls Biodesign Fistula Plug C-FPS-0.4-2 due to expiration before labeled date. Products may become ineffective or unsafe if used after expiration.
Products expire prior to the expiration date printed on the product labeling
Cook Biotech is recalling Biodesign Fistula Plugs that expire before the date printed on their labels. Using these products after expiration could lead to ineffective or unsafe medical outcomes.
The product expires before the expiration date printed on the label. This means the medical device may become ineffective or unsafe if used after its intended expiration date.
Patients who received the Biodesign Fistula Plug C-FPS-0.4-2 for recto-vaginal or anorectal fistula repair. Those with the specific lot numbers listed in the recall are most at risk.
Check the product label for the expiration date. The affected products have specific lot numbers: LB1524444, LB1524447, LB1524448, LB1524473, LB1525814, LB1530195, LB1534372, and LB1539163.
Verify the expiration date on the product label to ensure it matches the printed date.
The product expires before the expiration date printed on the label, which could lead to ineffective or unsafe medical outcomes.
The affected lot numbers are LB1524444, LB1524447, LB1524448, LB1524473, LB1525814, LB1530195, LB1534372, and LB1539163.
No, but you should check the expiration date on the label to ensure it hasn't expired before the printed date.
We’ve drafted a message you can send Cook Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-3256-2024 — Cook Biotech Cook Biotech Hello, I own a Cook Biotech that is covered by recall Z-3256-2024 from Cook Biotech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
