Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fis
FDA device recall Z-3259-2024 · posted 2024-09-25 · Open, Classified
Recall details
- Recalling firm
- Cook Biotech, Inc.
- Reason for recall
- Products expire prior to the expiration date printed on the product labeling
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Open, Classified
- Product code
- FTM
- Quantity affected
- 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 Kin
- Date initiated
- 2024-08-07
- Date posted
- 2024-09-25
- Location
- W Lafayette, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGISIS RVP RECTO-VAGINAL FISTULA PLUG (K062729) | Cook Biotech, Inc. | 2006-10-10 |