Cook Biotech recalls Biodesign Fistula Plug C-FPS-0.2-2 due to expiration before labeled date. This implantable device for recto-vaginal/anorectal repair may become ineffective or unsafe if used after expiration.
Products expire prior to the expiration date printed on the product labeling
Cook Biotech recalls its Biodesign Fistula Plug C-FPS-0.2-2 for implantation to repair recto-vaginal or anorectal fistulas because the product expires before the date printed on its label. Using it after expiration could make it ineffective or unsafe.
The product expires before the expiration date printed on the label. This means the device may become ineffective or unsafe if used after the labeled expiration date, potentially leading to complications in healing.
Patients who received this implantable device for recto-vaginal or anorectal fistula repair are likely affected. Those using the device after its expiration date may face reduced effectiveness.
Check for the product name 'Biodesign Fistula Plug C-FPS-0.2-2' and lot number LB1524446. The device is intended for implantation to repair recto-vaginal or anorectal fistulas.
Verify the product's expiration date against the label date. If it has expired, do not use the device.
The product expires before the expiration date printed on the label, which could make it ineffective or unsafe if used after expiration.
Check the expiration date on the label. If it has expired, do not use the device. Contact Cook Biotech for further guidance.
No fix is provided; the remedy is not stated 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-3255-2024 — Cook Biotech Cook Biotech Hello, I own a Cook Biotech that is covered by recall Z-3255-2024 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.
