Recall Z-1766-2017 ยท DXC Clamp, Vascular
Merit Medical Systems, Inc.
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and d
| Date | Apr 10, 2017 (initiated Mar 3, 2017) |
| Status | Terminated |
| Reason | Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve. |
| Root cause | Process control |
| Action | Merit Medical sent an Urgent Product Recall Notice on March 3, 2017, via letter for consignees to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact Merit Customer Service at (801) 208-4381. For further questions regarding this recall, please call (801) 253-1600. |
| Quantity | 1,940 units total |
| Distribution | Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162988 | PreludeSYNC Radial Compression Device Merit Medical Systems, Inc., Jan 25, 2017 |