Recall Z-1408-2013 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc.
Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
| Date | May 25, 2013 (initiated May 2, 2013) |
| Status | Terminated |
| Reason | Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape. |
| Root cause | Process control |
| Action | Merit sent an Urgent Product Recall Notice letter dated May 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to identify, quarantine, discontinue using products, and contact their sales representative to arrange product return and replacement or credit. For questions call 1-801-208-4468. |
| Quantity | 1,465 |
| Distribution | USA Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943739 | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Medical, Nov 15, 1994 |