Recall Z-1497-2017 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access
| Date | Mar 24, 2017 (initiated Feb 16, 2017) |
| Status | Terminated |
| Reason | Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use. |
| Root cause | Process control |
| Action | Consignees notified on 2/16/17 to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact your Merit Sales Representative or Merit Customer Service at 801.208.4381. |
| Quantity | 1,265 total |
| Distribution | Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082063 | PRELUDE SHORT SHEATH INTRODUCER Merit Medical Systems, Inc., Oct 15, 2008 |