Recall Z-0746-2010 ยท OEZ Cardiovascular Procedure Kit
Merit Medical Systems, Inc.
Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience.
| Date | Jan 29, 2010 (initiated Jan 29, 2009) |
| Status | Terminated |
| Reason | A manufacturing defect may prevent adequate sterilization of the entire device. |
| Root cause | Process control |
| Action | Applicable Merit sales representatives and distributors were notified by phone and letter beginning January 29, 2009 and instructed to immediately contact all affected consignees. Consignees were to immediately quarantine any remaining product and arrange for return to the firm. For further information, contact Merit Medical Systems, Inc. at 1-800-356-3748 extensions 4929 or 4998. |
| Quantity | 220 units |
| Distribution | Worldwide Distribution -- United States ( PA and TX) and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.