InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for
FDA device recall Z-1427-2010 · posted 2010-04-23 · Terminated
Recall details
- Recalling firm
- Intervascular S.A.S.
- Reason for recall
- Packaging was mislabeled.
- Action taken
- InterVascular SAS issued a "Recall Notification - Product Recall RC 020" notification dated January 29, 2009 to the sole consignee. The consignee had previously been notified by phone and all affected product had been segregated. For further information, contact InterVascular SAS at +33 442 08 77 84.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DSY
- Quantity affected
- 9
- Distribution
- Nationwide Distribution - Arizona.
- Date initiated
- 2009-12-09
- Date posted
- 2010-04-23
- Date terminated
- 2010-04-27
- 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 |