8 ml Inject8 Coronary Control Syringe, sterile.
FDA device recall Z-0048-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- Reason for recall
- Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
- Action taken
- All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 11, 332 syringes
- Distribution
- Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.
- Date initiated
- 2004-09-14
- Date posted
- 2004-10-28
- Date terminated
- 2005-03-31
- 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 |
|---|---|---|
| DISPOSABLE CORONARY CONTROL SYRINGE 12CC (K875196) | Merit Medical Systems, Inc. | 1988-02-11 |