ICU Medical, Inc. recalls 10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Che
Recalled Product
10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(17)250201(30)50(10)4713953; (01)10887709067322(17)250201(30)50(10)4730099; (01)10887709067322(17)250101(30)50(10)4599979; (01)10887709067575(17)250101(30)50(10)4589962; (01)10887709067575(17)250201(30)50(10)4711191;(01)10887709067575(17)250201(30)50(10)4733727. 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
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