FDA-Device2019-01-02Class II
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
ICU Medical, Inc.
Hazard
Potential for leakage due to defect in the thermoset check valve component.
Sold states
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
Affected count
25,640 units
Manufactured in
951 Calle Amanecer, San Clemente, CA, United States
Products
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0663-2019Don't want to check this manually?
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