Z-2485-2021 Class II Terminated
FDA device recall Z-2485-2021 was initiated by Greiner Bio-One North America, Inc. on Aug 13, 2021 and is designated Class II. Reason for recall: Blood collection tubes may experience a clotting issue. The recall status is terminated (terminated Aug 16, 2023). Affected quantity: 962,400 tubes.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 6, 2021
- Initiation Date
- Aug 13, 2021
- Termination Date
- Aug 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 962,400 tubes
Product Description
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Reason for Recall
Blood collection tubes may experience a clotting issue.
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.
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.