FDA recall Z-0662-2019

Product

Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 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-0662-2019