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Recall Observatory FDA recall evidence

Device product

greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P

Z-0502-2022

December 09, 2021

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 89216
Status
Terminated
Classification
Class II
Quantity
889,200 pcs.
Official record key
device-enforcement:Z-0502-2022

Official wording

Reason: Some of the blood collection tubes show clotting due to variation of Lithium Heparin.

Code information: Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.

Distribution pattern: Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some of the blood collection tubes show clotting due to variation of Lithium Heparin.