ICU Medical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2164-2014)

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:

Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Product Classification:

Class II

Date Initiated: July 18, 2014

Date Posted: August 13, 2014

Recall Number: Z-2164-2014

Event ID: 68971

Reason for Recall:

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Status: Terminated

Product Quantity: 640 units

Code Information:

Lot No. 2817530, 2852405, 2869455, 2883663

Distribution Pattern:

Worldwide Distribution - USA including Oregon and Internationally to Australia.

Voluntary or Mandated:

Voluntary: Firm initiated