Device recall: Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal…
Class II FDA enforcement event 95149. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Products expire prior to the expiration date printed on the product labeling
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Cook Biotech, Inc. started this device recall on 7 Aug 2024. The firm address in the FDA record is in W Lafayette, IN. FDA put the recall in Class II. FDA event 95149 has 12 product records. The first FDA enforcement report date is 2 Oct 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United…
Recalling firm
Cook Biotech, Inc., W Lafayette, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3250-2024 | Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667 | 1 unit | Class II | Ongoing | 2 Oct 2024 |
| Z-3251-2024 | Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668 | 3 units | Class II | Ongoing | 2 Oct 2024 |
| Z-3252-2024 | 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 | 35 units | Class II | Ongoing | 2 Oct 2024 |
| Z-3253-2024 | Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613 | 93 | Class II | Ongoing | 2 Oct 2024 |
| Z-3254-2024 | Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614 | 102 units | Class II | Ongoing | 2 Oct 2024 |
| Z-3255-2024 | Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374 | 5 units | Class II | Ongoing | 2 Oct 2024 |
| Z-3256-2024 | Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372 | 39 units | Class II | Ongoing | 2 Oct 2024 |
| Z-3257-2024 | Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373 | 130 units | Class II | Ongoing | 2 Oct 2024 |
| Z-3258-2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601 | 3 units | Class II | Ongoing | 2 Oct 2024 |
| Z-3259-2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602 | 5 units | Class II | Ongoing | 2 Oct 2024 |
| Z-3260-2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603 | 8 units | Class II | Ongoing | 2 Oct 2024 |
| Z-3261-2024 | Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603 | 120 units | Class II | Ongoing | 2 Oct 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 12Median of the firm: 12
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Nov 2024 | Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. | Device | Class II | 3 |
Official channels
- FDA enforcement report Z-3250-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95149. https://recallregister.com/fda/ii/95149/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United…
- What quantity of product is in FDA event 95149?
- The event has 12 product records. The first record gives this quantity:
1 unit
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.