Inject 10 Coronary Control Syringe (CCS), 10ml
FDA device recall Z-0912-03 · posted 2003-06-05 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- Reason for recall
- Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.
- Action taken
- On 5/16/2003, all distributors and consignees were notified by letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 7257 units
- Distribution
- Nationwide. Foreign distribution to France, Malaysia, Taiwan, Dominican Republic.
- Date initiated
- 2003-05-16
- Date posted
- 2003-06-05
- Date terminated
- 2003-07-21
- 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 |