medical Class II Updated 2020-10-28

ICU Medical, Inc. recalls 10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Ch

Recalled Product

10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743; (01)10887709080796(17)250101(30)50(10)4573956;(01)10887709080796(17)250101(30)50(10)4589954;(01)10887709080796(17)250101(30)50(10)4711180. 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:4536743, 4573956, 4589954, 4711180.
View official government recall

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