FDA recall Z-0069-2019

ICU Medical, Inc. · Class II · device

Product

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).

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.

Distribution

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

Key facts

Status
Completed
Initiation date
2018-08-20
Report date
2018-10-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2019