medical Class II Updated 2020-10-28

ICU Medical, Inc. recalls 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Che

Recalled Product

20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(17)250401(30)50(10)4803158; (01)10887709069203(17)250101(30)50(10)4558617; (01)10887709069203(17)250101(30)50(10)4589967. 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:4742130, 4803158, 4558617, 4589967.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →