InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated V
FDA device recall Z-1439-2010 · posted 2010-04-28 · Terminated
Recall details
- Recalling firm
- Intervascular S.A.S.
- Reason for recall
- The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.
- Action taken
- The firm sent recall letters to all customers on December 9, 12009. Calls had been made prior to the letter being sent. Because all product was recovered, no additional questions are anticipated.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSY
- Quantity affected
- 5
- Distribution
- US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.
- Date initiated
- 2009-12-09
- Date posted
- 2010-04-28
- Date terminated
- 2010-04-29
- Location
- La Ciotat Cedex, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES (K964625) | Intervascular, Inc. | 1997-05-05 |