ICU Medical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0697-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 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.

Product Classification:

Class II

Date Initiated: December 24, 2013

Date Posted: January 15, 2014

Recall Number: Z-0697-2014

Event ID: 67166

Reason for Recall:

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

Status: Terminated

Product Quantity: 500 units

Code Information:

Lot No. 2767376

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.

Voluntary or Mandated:

Voluntary: Firm initiated