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ICU Medical, Inc. recalls Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per
Recalled January 2, 2019 · FDA recall Z-0662-2019 · ICU Medical
Hazard
Potential for leakage due to defect in the thermoset check valve component. · FDA Class II
Units
1,760 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 #6x12x2.6 Cav/10 pieces per case R1-6090
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →