ICU Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0069-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 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).

Product Classification:

Class II

Date Initiated: August 20, 2018

Date Posted: October 10, 2018

Recall Number: Z-0069-2019

Event ID: 80946

Reason for Recall:

Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.

Status: Completed

Product Quantity: 2361 Units

Code Information:

lots: 85-540-SJ, 86-189-SL, 86-911-SJ

Distribution Pattern:

U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.

Voluntary or Mandated:

Voluntary: Firm initiated