medical Class II Updated 2020-10-28

ICU Medical, Inc. recalls PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoCla

Recalled Product

PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619093195(17)250101(30)50(10)4600271; (01)10840619093195(17)241201(30)50(10)4537220. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein


Hazard / Issue

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers:4600271, 4537220.
View official government recall

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