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-0.7 - 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

Lot, batch or date codesUDI: (01)00827002546141(17) Lot Number: LB1524449 LB1524454 LB1524460 LB1524465 LB1524482 LB1526801 LB1526803 LB1526900 LB1528808 LB1528812 LB1529886 LB1529893 LB1530966 LB1530984 LB1533320 LB1533329 LB1534893 LB1534902 LB1537013 LB1537052 LB1537834 LB1537846

Quantity recalled102 units

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-3254-2024
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-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614

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.

Nationwide

Questions about this recall

Why was it recalled?

Products expire prior to the expiration date printed on the product labeling

Which lots are affected?

UDI: (01)00827002546141(17) Lot Number: LB1524449 LB1524454 LB1524460 LB1524465 LB1524482 LB1526801 LB1526803 LB1526900 LB1528808 LB1528812 LB1529886 LB1529893 LB1530966 LB1530984 LB1533320 LB1533329 LB1534893 LB1534902 LB1537013 LB1537052 LB1537834 LB1537846

Where was it sold?

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 95149

This product is part of a recall event; the main page for the event is Biodesign Inguinal Hernia Graft C-ihm recalled by Cook Biotech.

Reported	Class	Recall	Company	Reason	Where
2 Oct 2024	CLASS II	Biodesign Inguinal Hernia Graft C-ihm recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fpb recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fpb recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide

More recalls from Cook Biotech

All 15

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Dural Graft recalled by Cook Biotech	Cook Biotech	Other	MI
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Otologic Butterfly Graft recalled by Cook Biotech	Cook Biotech	Other	MI
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Hiatal Hernia Graft recalled by Cook Biotech	Cook Biotech	Other	MI
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide

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14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide