medical Class II Updated 2021-08-18

Merit Medical Systems, Inc. recalls MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-

Recalled Product

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391


Hazard / Issue

There is a potential that a package sheath contains an incorrect dilator.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # H2069291
View official government recall

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