Class 2 Device Recall Biodesign Fistula Plug

• Date Initiated by Firm: August 07, 2024
• Date Posted: September 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3253-2024
• Recall Event ID: 95149
• 510(K)Number: K062729
• Product Classification: Mesh, surgical - Product Code FTM
• Product: 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
• Code Information: UDI: (01)00827002546134(17) Lot Number: LB1524439 LB1524440 LB1524442 LB1524443 LB1524445 LB1524463 LB1524466 LB1524468 LB1524475 LB1524479 LB1524481¿ LB1524490 LB1524493 LB1525896 LB1525901 LB1525907 LB1526905 LB1527067 LB1527075 LB1530306 LB1530313 LB1531711 LB1531739 LB1533341 LB1533352 LB1536078 LB1536107 LB1537839 LB1537859 LB1539734 LB1539735 LB1540185
• Recalling Firm/ Manufacturer: Cook Biotech, Inc.; 1425 Innovation Pl; W Lafayette IN 47906-1000
• For Additional Information Contact: SAME; 765-497-3355
• Manufacturer Reason for Recall: Products expire prior to the expiration date printed on the product labeling
• FDA Determined 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 (FieldActionsNA@CookMedical.com). 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: CustomerRelationsNA@CookMedical.com. 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: 93
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FTM