medical Class II Updated 2019-01-02

ICU Medical, Inc. recalls Thermoset Room Temperature Closed Loop Injectate Delivery Sy

Recalled Product

Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 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:41412-01. Lot number (UDI): 3591489 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3591489); 3598125 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3598125); 3608570 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3608570); 3610798 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3610798); 3618041 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3618041); 3656677 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3656677); 3665611 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3665611). Expiration Date 01/01/2021.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →