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Merit Medical Systems, Inc. recalls Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only,
Recalled August 18, 2021 · FDA recall Z-2239-2021 · Merit Medical Systems
Hazard
There is a potential that 7F sheaths are packaged as 10F sheaths. · FDA Class II
Units
760 UNITS
Sold at
US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway
Description
There is a potential that 7F sheaths are packaged as 10F sheaths.
Product
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →