FDA recall Z-2507-2021

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

Product

Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

Reason for recall

Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.

Distribution

US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2021-08-20
Report date
2021-09-29
Termination date
2023-10-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroe, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2507-2021