HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; H
FDA device recall Z-0638-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Datascope Corporation
- Reason for recall
- Water permeability of the patch is out of specification.
- Action taken
- Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSY
- Quantity affected
- 710 units
- Distribution
- The product has been shipped nationwide to 53 hospitals, 4 government hospitals, and 3 sales representatives.
- Date initiated
- 2003-12-30
- Date posted
- 2004-07-20
- Date terminated
- 2006-01-19
- Location
- Montvale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN (K983819) | Intervascular, Inc. | 1998-11-24 |