Cook Biotech recalls Biodesign Fistula Plug C-FPB-0.7 due to expiration before labeled date. Affected units may cause complications if used after expiry.
Products expire prior to the expiration date printed on the product labeling
Cook Biotech is recalling Biodes:design Fistula Plug C-FPB-0.7 implants because they expire before the date printed on the product. Using expired implants could lead to complications in surgical repairs.
The product expires before the expiration date printed on the label. Using expired implants could lead to complications during surgical repairs, such as infection or improper healing.
Patients who received the Biodesign Fistula Plug C-FPB-0.7 for recto-vaginal or anorectal fistula repair. Those with implants that expired before the labeled date are most at risk.
Check for the lot numbers LB1536090 or LB1536126 on the product packaging. The product is labeled for implantation to repair recto-vaginal or anorectal fistulas.
Verify the product's expiration date against the label to ensure it hasn't expired before the printed date.
The product expires before the expiration date printed on the label, which could lead to complications if used after expiry.
Check the expiry date on the label. If expired, contact Cook Biotech for guidance.
Look for lot numbers LB1536090 or LB1536126 on the product packaging.
We’ve drafted a message you can send Cook Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-3251-2024 — Cook Biotech Cook Biotech Hello, I own a Cook Biotech that is covered by recall Z-3251-2024 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.
