Merit Custom Procedure Kit
FDA device recall Z-0080-06 · posted 2005-10-21 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- Reason for recall
- Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Action taken
- Consignees were notified by letter on 9/2/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 372 units
- Distribution
- DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts.
- Date initiated
- 2005-09-02
- Date posted
- 2005-10-21
- Date terminated
- 2005-10-28
- 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 |
|---|---|---|
| MERIT CUSTOM KIT (K913682) | Merit Medical Systems, Inc. | 1991-11-15 |