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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Becton Dickinson & Company: False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

Agency Publication Date: August 21, 2019
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Affected Products

Product: BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880

UDI: (01)30382903678809

Product: BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884

UDI: (01)30382903678847

Product: BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886

UDI: (01)30382903678861

Product: BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960

UDI: (01)30382903679608

Product: BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961

UDI: (01)30382903679615

Product: BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962

UDI: (01)30382903679622

Product: BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963

UDI: (01)30382903679639

Product: BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964

UDI: (01)30382903679646

Product: BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036

UDI: (01)30382903680352, (01)30382903680369

Product: BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056

UDI: (01)30382903680567

Product: BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494

UDI: (01)30382903680352

Product: BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884

UDI: (01)30382903659037

Product: BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886

UDI: (01)30382903666646

Product: BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664

UDI: (01)30382903666646

Product: BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667

UDI: (01)30382903666677

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82963
Status: Resolved
Manufacturer: Becton Dickinson & Company
Manufactured In: United States
Units Affected: 15 products (1,436,228,004 total)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.