Recall Z-0614-2014 ยท KRA Catheter, Continuous Flush
Merit Medical Systems, Inc.
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
| Date | Dec 31, 2013 (initiated Dec 6, 2013) |
| Status | Terminated |
| Reason | Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match. |
| Root cause | Packaging process control |
| Action | Merit Medical Systems sent an Urgent Product Recall Notice dated December 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of the Maestro Microcatheters identified and isolate them in a quarantined area until the product is over-labeled by their Merit Sales Representative Customers were instructed to ensure that all personnel to whom the devices were distributed were made aware of the field action. Customers with questions were instructed to contact their |
| Quantity | 59 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082613 | MERIT MICROCATHETER Merit Medical Systems, Inc., Dec 30, 2008 |