FDA recall Z-0661-2019

ICU Medical, Inc. · Class II · device

Product

Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-10-05
Report date
2019-01-02
Termination date
2021-03-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0661-2019