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
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-3257-2024
- Quantity
- 130 units
- 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)00827002463738(17)250319(10)LB1524437 (01)00827002463738(17)250319(10)LB1524441 (01)00827002463738(17)250319(10)LB1524453 (01)00827002463738(17)250402(10)LB1524456 (01)00827002463738(17)250319(10)LB1524457 (01)00827002463738(17)250402(10)LB1524484 (01)00827002463738(17)250408(10)LB1524495 (01)00827002463738(17)250402(10)LB1525243 (01)00827002463738(17)250416(10)LB1525244 (01)00827002463738(17)250402(10)LB1525249 (01)00827002463738(17)250416(10)LB1528983 (01)00827002463738(17)250416(10)LB1528999 (01)00827002463738(17)250416(10)LB1529377 (01)00827002463738(17)250626(10)LB1529380 (01)00827002463738(17)250429(10)LB1529383 (01)00827002463738(17)250419(10)LB1529680 (01)00827002463738(17)250429(10)LB1530192 (01)00827002463738(17)250429(10)LB1530299 (01)00827002463738(17)250429(10)LB1530308 (01)00827002463738(17)250520(10)LB1530309 (01)00827002463738(17)250523(10)LB1530310 (01)00827002463738(17)250531(10)LB1531363 (01)00827002463738(17)250531(10)LB1531404 (01)00827002463738(17)250531(10)LB1531406 (01)00827002463738(17)250603(10)LB1534887 (01)00827002463738(17)250626(10)LB1534888 Lot Number: LB1524437 LB1524441 LB1524453 LB1524456 LB1524457 LB1524484 LB1524495 LB1525243 LB1525244 LB1525249 LB1528983 LB1528999 LB1529377 LB1529380 LB1529383 LB1529680 LB1530192 LB1530299 LB1530308 LB1530309 LB1530310 LB1531363 LB1531404 LB1531406 LB1534887 LB1534888
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.