UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
FDA device recall Z-0158-04 · posted 2003-11-27 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- Reason for recall
- Angiographic catheter tips may separate during use.
- Action taken
- All 7 consignees were contacted by their sales representatives on 11/5-7/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 410 units
- Distribution
- FL, MI, NY, PA, TN, TX. No foreign, government, or military distribution.
- Date initiated
- 2003-11-05
- Date posted
- 2003-11-27
- Date terminated
- 2003-12-01
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER (K943739) | Mallinckrodt Medical | 1994-11-15 |