medical Class II Updated 2020-10-28

ICU Medical, Inc. recalls 58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoCl

Recalled Product

58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460; (01)10887709095298(17)250101(30)25(10)4589956; (01)10887709095298(17)250201(30)25(10)4711185. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a 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:4573460, 4589956, 4711185.
View official government recall

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