Recall Z-0554-2011 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc.
Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09304, Revision B, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
| Date | Dec 8, 2010 (initiated Oct 25, 2010) |
| Status | Terminated |
| Reason | Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint. |
| Root cause | Process control |
| Action | Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748. |
| Quantity | 679 units |
| Distribution | Nationwide Distribution in the states of CA, IL, IN, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913682 | MERIT CUSTOM KIT Merit Medical Systems, Inc., Nov 15, 1991 |