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Recall Observatory FDA recall evidence

Device product

NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

Z-0658-2014

December 24, 2013

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 67166
Status
Terminated
Classification
Class II
Quantity
69100 units
Official record key
device-enforcement:Z-0658-2014

Official wording

Reason: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

Code information: Lot No. 2766916 2781527 2776455 2767054 2768331 2770578 2781554 2785375 2767355 2783362 2787992 34-463-HE

Distribution pattern: Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.