Recall Z-0688-2018 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5
| Date | Dec 14, 2017 |
| Status | Terminated |
| Reason | Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub. |
| Root cause | Under Investigation by firm |
| Action | Communication to consignees began on December 14, 2017. Merit requested that consignees stop using the PreludeSNAP devices for human use, discontinue distribution, and return remaining product to Merit Medical. |
| Quantity | 60,945 devices |
| Distribution | US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain |
| FDA record | Open on fda.gov |