Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah.
FDA device recall Z-0847-2007 · posted 2007-05-31 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Male luer in fluid administration sets may crack due to inadequate molding process
- Action taken
- Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMG
- Quantity affected
- 17 units
- Distribution
- CA, IL, NJ, NY. No military, government or foreign distribution.
- Date initiated
- 2007-04-17
- Date posted
- 2007-05-31
- Date terminated
- 2008-05-05
- 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 ADMINISTRATION SET (K915678) | Merit Medical Systems, Inc. | 1992-07-30 |