Custom Angiographic Kit
FDA device recall Z-0622-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- Reason for recall
- A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Action taken
- Consignees were notified by phone and FAX on 2/12/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 82 kits.
- Distribution
- FL and Japan.
- Date initiated
- 2003-02-13
- Date posted
- 2003-03-06
- Date terminated
- 2003-03-07
- 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 |
|---|---|---|
| MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) (K973230) | Merit Medical Systems, Inc. | 1997-11-25 |
| STOPCOCK (ONE-PORT MANIFOLD) (K934123) | Merit Medical Systems, Inc. | 1993-11-23 |
| MERIT CUSTOM KIT (K913682) | Merit Medical Systems, Inc. | 1991-11-15 |
| MERIT HI-FLEX(TM) (K883718) | Merit Medical Systems, Inc. | 1989-01-30 |