NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assembli
FDA device recall Z-0287-2009 · posted 2008-11-09 · Terminated
Recall details
- Recalling firm
- Navilyst Medical
- Reason for recall
- Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.
- Action taken
- On 8/12/08, Navilyst Medical sent a fax and phoned the sole domestic hospital account that had received the affected units. Navilyst Medical instructed the consignee to immediately locate, segregate, and quarantine the units. The hospital consignee confirmed that all units were still in their control and that they will maintain them in quarantine awaiting return to Navilyst Medical. The sole international account, Boston Scientific in Ireland was notified of the problem on 8/06/08. This was followed up with an Urgent Medical Device Recall Letter and Verification Form sent via FedEx on 8/20/08.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- Domestic - 20 units; Foreign - 16,200 bulk units
- Distribution
- Worldwide Distribution --- USA including state of MO and country of Ireland.
- Date initiated
- 2008-08-06
- Date posted
- 2008-11-09
- Date terminated
- 2009-06-16
- 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 |