Cook Biotech recalls Biodesign Fistula Plug C-FPS-0.7-2 due to expiration prior to printed date on label. Affected units have specific lot numbers and order numbers.
Products expire prior to the expiration date printed on the product labeling
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.7-2 implants because they expire before the date printed on their label. This means the product may not be safe for use once the expiration date passes.
The product expires before the expiration date printed on the label. This means the implant could become ineffective or unsafe after the intended use period ends, potentially leading to complications in healing.
Patients who received the Biodesign Fistula Plug C-FPS-0.7-2 for recto-vaginal or anorectal fistula repair. Those with the specific lot numbers listed in the recall are most at risk.
Check for the lot numbers listed: LB1524437 through LB1534888. The product has an order number (GPN) of G46373 and a unique identifier (UDI) starting with (01)00827002463738.
Look for the expiration date printed on the product label and compare it to the product's intended expiration date.
The product expires before the expiration date printed on the label, which could lead to ineffective or unsafe use after the intended period.
Lot numbers LB1524437 through LB1534888 are affected.
Check the product label for the order number (GPN) G46373 and lot numbers listed in the recall notice.
We’ve drafted a message you can send Cook Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-3257-2024 — Cook Biotech Cook Biotech Hello, I own a Cook Biotech that is covered by recall Z-3257-2024 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.
