Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 Recalled by ICU Medical, Inc. Due to Potential for leakage due to defect in the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.
Affected 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
Quantity: 25,640 units
Why Was This Recalled?
Potential for leakage due to defect in the thermoset check valve component.
Where Was This Sold?
This product was distributed to 31 states: AL, CA, CO, FL, GA, IN, KY, LA, ME, MD, MA, MI, MS, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WI, WY, DC
About ICU Medical, Inc.
ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report