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Recall Observatory FDA recall evidence

Device product

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

Z-2507-2021

August 20, 2021

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 88563
Status
Terminated
Classification
Class II
Quantity
956,400
Official record key
device-enforcement:Z-2507-2021

Official wording

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

Code information: Lot # B210533B Expiration 05/10/22 and B210439J Expiration 04/13/2022.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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