ICU Medical, Inc. recalls 13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear,
Recalled Product
13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)10887709085227(17)250101(30)50(10)4589920; (01)10887709085227(17)250101(30)50(10)4572950. 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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