Cook Biotech recalls Biodesign Fistula Plug C-FPS-0.4 implants that expire before their printed expiration date. This may lead to ineffective treatment for recto-vaginal or anorectal fistulas.
Products expire prior to the expiration date printed on the product labeling
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.4 implants that expire before their printed expiration date. Using expired implants could lead to ineffective treatment for recto-vaginal or anorectal fistulas.
The product expires before the expiration date printed on the label. This means the implant may not be effective for its intended use, potentially leading to treatment failure.
Patients who received the Biodesign Fistula Plug C-FPS-0.4 implant 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 and lot number. The affected lot numbers include LB1524439 through LB1540185 as listed in the recall.
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 may lead to ineffective treatment for recto-vaginal or anorectal fistulas.
Lot numbers LB1524439 through LB1540185 as listed in the recall.
No, but you should check the expiration date 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-3253-2024 — Cook Biotech Cook Biotech Hello, I own a Cook Biotech that is covered by recall Z-3253-2024 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.
