ICU Medical, Inc. recalls Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per c

Recalled January 2, 2019 · FDA recall Z-0663-2019 · ICU Medical

Hazard

Potential for leakage due to defect in the thermoset check valve component. · FDA Class II

Units

25,640 units

Sold at

United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO, MS, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY

Description

Potential for leakage due to defect in the thermoset check valve component.

Product

Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645

Manufacturer(s)

ICU Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →