''NAMIC Custom Angiographic Kit'' sold under the following labels: (1) Medical University of South Carolina. Pouch Catal
FDA device recall Z-1393-05 · posted 2005-08-24 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Molded handles used in Angiographic Manifolds may be occluded.
- Action taken
- Letters dated 5/4/2004 to Risk Managers with instructions to return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 1115 kits
- Distribution
- The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.
- Date initiated
- 2004-05-05
- Date posted
- 2005-08-24
- Date terminated
- 2005-08-31
- Location
- Glens Falls, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STOPCOCKS, MANIFOLDS (K782095) | Namic | 1979-01-23 |