medical Class II Updated 2020-10-28

ICU Medical, Inc. recalls NanoClave Connector; 1 unit per pouch, 100 multivac pouches

Recalled Product

NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754 CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery.

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: 4549051, 4447754.
View official government recall

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