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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

Stryker Corporation: Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

Agency Publication Date: April 4, 2023
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Affected Products

Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

GTIN: 07613327606157 Lot Numbers; 2022111803 2022112901 2022121911 2022121912 2022122601 2022122602

Lot Numbers:
Numbers
Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

GTIN: 07613327606195 Lot Numbers: 2022111804 2022112902 2022121909 2022121910 2022122603 2022122604

Lot Numbers:
Numbers
Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

GTIN: 07613327606171 Lot Numbers: 2022111805 2022112801 2022112803 2022112804 2022112805 2022112806 2022112807 2022112808 2022120506 2022120507 2022120508

Lot Numbers:
Numbers
Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

GTIN: 07613327606188 Lot Numbers: 2022111806 2022112802 2022120501 2022120502 2022120503 2022120504 2022120505 2022120701

Lot Numbers:
Numbers
Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS

GTIN: 07613327606133 Lot Numbers: 2022111801 2022112903 2022121201 2022121202 2022121203 2022121204 2022121205 2022121206

Lot Numbers:
Numbers
Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

GTIN: 07613327606164 Lot Numbers: 2022111802 2022112904 2022121301 2022121302 2022121905 2022121906 2022121907 2022121908

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91849
Status: Active
Manufacturer: Stryker Corporation
Manufactured In: United States
Units Affected: 6 products (1225 units (packs of 10); 1206 units (packs of 10); 1979 units (packs of 10); 1617 units (packs of 10); 1730 units (packs of 10); 1707 units (packs of 10))

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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.