Recall Z-0045-2014 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc.
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
| Date | Oct 22, 2013 (initiated Sep 13, 2013) |
| Status | Terminated |
| Reason | 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. |
| Root cause | Process control |
| Action | Consignees were notified on 9/13/13 via Urgent Product Recall Notice, email, and product retrieval forms. Actions required of customers: 1. Please immediately determine if any of the devices are within your facility, quarantine them and discontinue use. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Contact your Merit Sales Representative in order to arrange product return and replacement or credit. 4. If you have any questions concerning this communication, please don't hesitate to contact Guido Sandulli at 1-801-826-4046. |
| Quantity | 200 |
| Distribution | US Distribution including the states of CO, VA, and MS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943739 | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Medical, Nov 15, 1994 |