FDA-Device2021-08-18Class II
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Hazard
There is a potential that 7F sheaths are packaged as 10F sheaths.
Sold states
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
Affected count
760 units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2021More Merit Medical Systems, Inc. recalls
- FDA-Device2026-06-24Merit Medical Splashwire Hydrophilic Guide Wire recalled for unsealed pouches
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