medical Class II Updated 2019-01-02

ICU Medical, Inc. recalls Iced Thermoset Closed-Loop Injectate Delivery System for col

Recalled Product

Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Item number: 41423-03. Lot numbers 3593903, UDI (01) 0 0840619 06347 4 (17) 201201(30) 01 (10)3593903. Lot number 3598129, UDI (01) 0 0840619 06347 4 (17) 201201(30) 01 (10)3598129. Expiration Date 12/01/2020.
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