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
This recall is currently active, issued September 25, 2024. It was issued by Cook Biotech, Inc..
- Company
- Cook Biotech, Inc.
- Recall Initiated
- August 7, 2024
- Posted
- September 25, 2024
- Recall Number
- Z-3253-2024
- Quantity
- 93
- Firm Location
- W Lafayette, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Products expire prior to the expiration date printed on the product labeling
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.
Lot / Code Info
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
Root Cause
Incorrect or no expiration date
Action Taken
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.