Z-3255-2024Class II

Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or...

Name: Z-3255-2024 Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or...
Creator: Cook Biotech, Inc.
Published: 2024-08-07
License: https://open.fda.gov/license/

Cook Biotech, Inc. / initiated 2024-08-07 / Open, Classified / root cause: labeling and UDI

FDA source

Cook Biotech, Inc. began a recall of 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 on 2024-08-07. FDA classified it as Class II and gives the reason as "Products expire prior to the expiration date printed on the product labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3255-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-07
Posted: 2024-09-25
Recalling firm: Cook Biotech, Inc.
Product: 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
Product code: FTM Mesh, Surgical
Reason for recall: Products expire prior to the expiration date printed on the product labeling
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Cook Biotech Inc. issued Urgent: Medical Device Recall Letter on 8/7/24. Letter states reason for recall, health risk and action to take: 1. Examine inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of Biodesign Fistula Plugs with Lot Numbers provided in the Product Information section of this letter. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Note: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. Cook Biotech initiated CAPA 2024-CR-002 for this issue. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in commerce: 5 units
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 Kingdom.
Product codes and lots: UDI: (01)00827002463745(17)250319(10)LB1524446 Lot Number: LB1524446

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3255-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3250-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3251-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3252-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3253-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3254-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3255-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3256-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3257-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3258-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3259-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3260-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25
Z-3261-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-25

Product code FTM

K062729Class IISurgisis Rvp Recto-Vaginal Fistula PlugCook Biotech, Inc. / cleared 2006-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)