medical Class II Updated 2021-08-18

Merit Medical Systems, Inc. recalls Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010,

Recalled Product

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 / Issue

There is a potential that 7F sheaths are packaged as 10F sheaths.

Issued by

FDA

Affected States: 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
Lot/Code Info: Lot #I2067768
View official government recall

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