Device product
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Z-0662-2019
Product summary
- Event
- Event 81210
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,760 units
- Official record key
device-enforcement:Z-0662-2019
Official wording
Reason: Potential for leakage due to defect in the thermoset check valve component.
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
Derived failure modes
-
Unknown
Potential for leakage due to defect in the thermoset check valve component.