FDA recall Z-2485-2021

Greiner Bio-One North America, Inc. · Class II · device

Product

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

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.

Key facts

Status
Terminated
Initiation date
2021-08-13
Report date
2021-10-06
Termination date
2023-08-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroe, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2485-2021