Cook Biotech recalls Biodesign Fistula Plug C-FPS-0.7 due to expiration before labeled date. Products may not be safe for use after expiration.
Products expire prior to the expiration date printed on the product labeling
Cook Biotech recalls its Biodesign Fistula Plug C-FPS-0.7 for implantation to repair recto-vaginal or anorectal fistulas because the product expires before the date printed on its label. This means the device may not be safe for use once it expires.
The product expires before the expiration date printed on its label. Using an expired medical device could lead to reduced effectiveness or potential complications during healing.
Patients who received the Biodesign Fistula Plug C-FPS-0.7 for surgical repair of recto-vaginal or anorectal fistulas are likely affected. Medical professionals using this device for implantation are at risk if the product has expired.
Check the product label for the expiration date and lot numbers: LB1524449 through LB1537846. The device is used for implantation to repair recto-vaginal or anorectal fistulas.
Verify the expiration date on the product 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 reduced effectiveness or complications.
This device is used for implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Check the product label for lot numbers: LB1524449 through LB1537846.
We’ve drafted a message you can send Cook Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-3254-2024 — Cook Biotech Cook Biotech Hello, I own a Cook Biotech that is covered by recall Z-3254-2024 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.
