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Merit Medical Systems, Inc. recalls PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-10
Recalled February 28, 2018 · FDA recall Z-0688-2018 · Merit Medical Systems
Hazard
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. · FDA Class II
Units
60,945 devices
Sold at
US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain
Description
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.
Product
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
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →