Cook Biotech recalls Biodesign Fistula Plug C-FPS-0.2 implants due to expiration before labeled date. Affected units have specific lot numbers. Contact for return instructions.
Products expire prior to the expiration date printed on the product labeling
Cook Biotech recalls certain Biodesign Fistula Plug C-FPS-0.2 implants because they expire before the date printed on the product. This could lead to improper healing or infection if used after expiration.
The product expires before the expiration date printed on the label. Using expired medical implants could lead to improper healing or infection if the implant is used after its expiration date.
Patients who received the Biodesign Fistula Plug C-FPS-0.2 implant for recto-vaginal or anorectal fistula repair. Those with specific lot numbers are most at risk.
Check the lot numbers: LB1524461, LB1524469, LB1524472, LB1524486, LB1529402, LB1531398, LB1537840, LB1537858. The product is for implantation to reinforce soft tissue for recto-vaginal or anorectal fistula repair.
Verify the expiration date on the product label against the printed expiration date to ensure it hasn't expired.
The Biodesign Fistula Plug C-FPS-0.2 is used for implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Affected lot numbers are LB1524461, LB1524469, LB1524472, LB1524486, LB1529402, LB1531398, LB1537840, LB1537858.
The recall record does not specify a return or remedy action, so no action is required beyond checking the expiration 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-3252-2024 — Cook Biotech Cook Biotech Hello, I own a Cook Biotech that is covered by recall Z-3252-2024 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.
