FDADecember 14, 2017device
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
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
merit medical systemsmeritmerit medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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