Recall Z-1731-2010 ยท DQO Catheter, Intravascular, Diagnostic
Merit Medical Systems, Inc.
Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
| Date | May 28, 2010 (initiated May 5, 2010) |
| Status | Terminated |
| Reason | Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands. |
| Root cause | Process control |
| Action | Merit Medical Systems, Inc. began notifying sales representatives beginning May 5, 2010 via phone and instructed to contact all of their affected accounts. All affected product was to be returned to the firm. For further information, contact Merit Medical at 1-713-757-5067 or 1-801-208-4468. |
| Quantity | 96 units |
| Distribution | Nationwide Distribution -- GA, IL, MO, NY, PA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000659 | MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT Merit Medical Systems, Inc., Mar 29, 2000 |