Stryker Tourniquet Cuff Pressure Failure May Cause Bleeding
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or maintain desired pressure during surgical setup, potentially causing operative site bleeding or hemorrhage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for serious surgical complications including hemorrhage. No illnesses or injuries have been reported in the source; the hazard is based on the documented defect mechanism and theoretical harm.
Plain-English summary
Stryker Corporation is recalling specific lots of Color Cuff Non-Sterile Disposable Tourniquet Cuffs due to a pressure failure defect. The affected product is catalog number 5921-218-235NS, distributed nationwide.
The recalled cuffs may not achieve the desired pressure or may fail to hold pressure during initial cuff setup on the patient. This defect can result in operative site blood loss, hemorrhage, or in rare cases, other serious surgical complications. A total of 1,707 units have been distributed.
Affected lot numbers are: 2022111802, 2022112904, 2022121301, 2022121302, 2022121905, 2022121906, 2022121907, 2022121908. Healthcare facilities should identify and quarantine affected inventory and verify proper pressure maintenance during setup procedures before patient use.
The recalled product
- 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
- Manufacturer
- Stryker Corporation
- Hazard
- pressure-failure
- hemorrhage
- blood-loss
Distribution
Distributed nationwide across the United States.
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