Skip to content
Recall Observatory FDA recall evidence

Device product

VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

Z-2485-2021

August 13, 2021

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
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

    reason.no_named_rule · v1.0.0

    Blood collection tubes may experience a clotting issue.