Recall Z-0578-2009 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc.
Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095
| Date | Jan 13, 2009 (initiated Sep 12, 2008) |
| Status | Terminated |
| Reason | Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748. |
| Root cause | Process control |
| Action | All consignees were notified by sales reps via phone, fax or visit between 09/15/2008 and 10/09/2008. Sales reps were to instruct them to immediately discontinue use and quarantine all affected products. A Product Retrieval Form was to be completed and signed by the customer's site representative. More information available at 801-316-4998. |
| Quantity | 399 kits |
| Distribution | United States including the states of AR, AZ, CA, CO, FL, KY, IL, IN, MA, MI, MN, MO, NJ, NY, PA, SC, TX, UT, VA, WI, and WV. No military or foreign distribution. VA facilities in CA and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913682 | MERIT CUSTOM KIT Merit Medical Systems, Inc., Nov 15, 1991 |