Recall Z-0845-2007 ยท FMG Stopcock, I.V. Set
Merit Medical Systems, Inc.
Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, Merit Medical Systems, Inc., South Jordan, Utah 84095.
| Date | May 31, 2007 (initiated Apr 17, 2007) |
| Status | Terminated |
| Reason | Male luer in fluid administration sets may crack due to inadequate molding process |
| Root cause | Other |
| Action | Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product. |
| Quantity | 400 units |
| Distribution | CA, IL, NJ, NY. No military, government or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915678 | MERIT ADMINISTRATION SET Merit Medical Systems, Inc., Jul 30, 1992 |