Reported Feb 28, 2018 · Terminated
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008,…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- 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
- Lot codes and dates
- Lot Numbers
Q1176348Q1178762Q1194660Q1206565Q1201803Q1209475Q1213042Q1228339Q1234189X1Q1234639Q1182862Q1190097Q1194661Q1197055Q1202959Q1213024Q1215467Q1234979Q1174112Q1197331Q1176349Q1213048Q1182863Q1228338Q1194041Q1206577Q1214620Q1184987Q1194664Q1213051Q1237072Q1213018Q1205118Q1175815Q1194665Q1197054Q1193985Q1193397Q1209478Q1228340Q1176347Q1204708Q1182836Q1170938Q1161477Q1185050Q1234958Q1176345Q1193391Q1228356Q1175817Q1194663Q1215702Q1228354Q1201789
- Lot Numbers
- Amount recalled
- 60,945 devices
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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