CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
Biodesign Fistula Plug C-fps recalled by Cook Biotech
Cook Biotech is recalling Biodesign Fistula Plug C-fps-0.2 - For implantation to reinforce soft tissue for repair, distributed nationwide in the US. The recall was initiated on 7 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3252-2024
- FDA event ID
- 95149
- Recalling firm
- Cook Biotech, W Lafayette, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Aug 2024
- FDA classified
- 25 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Aug 2024 | Recall initiated by company | |
| 25 Sep 2024 | Classified by FDA | +49 days |
| 2 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products expire prior to the expiration date printed on the product labeling
Product as listed by the FDA
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.
Questions about this recall
Is Biodesign Fistula Plug C-fps-0.2 - For implantation to reinforce soft tissue for repair recalled?
Yes. Cook Biotech recalled Biodesign Fistula Plug C-fps-0.2 - For implantation to reinforce soft tissue for repair on 7 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-3252-2024.
Why was it recalled?
Products expire prior to the expiration date printed on the product labeling
Which lots are affected?
UDI: (01)00827002546127(17) Lot Number: LB1524461 LB1524469 LB1524472 LB1524486 LB1529402 LB1531398 LB1537840 LB1537858
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cook Biotech
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cook Medical Biodesign Dural Graft recalled by Cook Biotech | Cook Biotech | Sterility | MI |
| Device | CLASS II | Cook Medical Biodesign Otologic Butterfly Graft recalled by Cook Biotech | Cook Biotech | Sterility | MI |
| Device | CLASS II | Cook Medical Biodesign Hiatal Hernia Graft recalled by Cook Biotech | Cook Biotech | Sterility | MI |
| Device | CLASS II | Biodesign Fistula Plug C-fps recalled by Cook Biotech | Cook Biotech | Other | Nationwide |
| Device | CLASS II | Biodesign Fistula Plug C-fps recalled by Cook Biotech | Cook Biotech | Other | Nationwide |
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