Blood collection tubes recalled due to potential clotting defect
Greiner Bio-One North America is recalling VACUETTE blood collection tubes (6 ml K2E) because they may experience a clotting issue. Approximately 962,400 tubes were distributed across 15 US states and Canada.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device with no reported adverse events, illnesses, or hospitalizations. The recall addresses a potential defect (clotting issue) but the source text does not document injuries or confirmed harm.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling VACUETTE TUBE 6 ml K2E K2EDTA blood collection tubes (pink cap and pink ring, non-ridged) due to a potential clotting issue.
Approximately 962,400 tubes were affected. Distribution was made to healthcare facilities in Alabama, Arizona, Colorado, Connecticut, Florida, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Mexico, Pennsylvania, Texas, and Virginia, as well as to Canada.
The affected lots are Lot B21033DA (expiration date 09/08/2022) and Lot B21053R8 (expiration date 11/10/2022), both identified by Item Number 456279. Healthcare facilities that have received these tubes should identify affected inventory using the lot numbers and expiration dates provided.
The recalled product
- Product
- VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
- Manufacturer
- Greiner Bio-One North America, Inc.
- Hazard
- clotting
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distributed in 15 states:
- AL
- AZ
- CO
- CT
- FL
- IL
- MA
- MD
- MI
- MO
- NC
- NM
- PA
- TX
- VA
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