ICU Medical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0662-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 5, 2018

Date Posted: January 2, 2019

Recall Number: Z-0662-2019

Event ID: 81210

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,760 units

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated