Device product
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Z-2485-2021
Product summary
- Event
- Event 88511
- Status
- Terminated
- Classification
- Class II
- Quantity
- 962,400 tubes
- Official record key
device-enforcement:Z-2485-2021
Official wording
Reason: Blood collection tubes may experience a clotting issue.
Code information: Item Number 456279, Lot B21033DA, exp. 09/08/2022, UDI Case - 39120017571248; UDI Rack - 29120017571241 UPDATE per 9/10/2021 email: Item Number 456279, Lot B21053R8, exp. 11/10/2022, UDI Case -39120017571248; UDI Rack - 29120017571241.
Distribution pattern: Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.
Derived failure modes
-
Unknown
Blood collection tubes may experience a clotting issue.