Stryker Tourniquet Cuff Pressure Failure May Cause Hemorrhage During Surgery
Stryker tourniquet cuffs may fail to maintain proper pressure during initial setup, potentially causing operative blood loss or hemorrhage during surgical procedures.
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: This is an FDA Class II recall of surgical equipment with potential for serious patient harm (hemorrhage) from pressure failure during use. However, no injuries or hospitalizations have been reported, and the hazard represents a risk-of-harm scenario rather than demonstrated harm, placing it in the High severity category.
Plain-English summary
Stryker Corporation is recalling 1,206 units of the Color Cuff Non-Sterile Disposable Tourniquet Cuff (Catalog number 5921-030-235NS) used in surgical procedures to temporarily stop blood flow to a patient's extremities. Affected lot numbers are 2022111804, 2022112902, 2022121909, 2022121910, 2022122603, and 2022122604.
The cuffs may fail to achieve or maintain the desired pressure during initial setup on the patient. Two different causes for this failure have been reported. The pressure failure could result in operative site blood loss or hemorrhage, and in very rare situations, other serious complications.
The cuffs were distributed nationwide. The recall affects healthcare facilities and surgical settings where these tourniquet cuffs are used.
Healthcare providers using these cuffs should contact Stryker or their medical device supplier for instructions regarding the affected units.
The recalled product
- 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
- Manufacturer
- Stryker Corporation
- Hazard
- pressure-failure
- hemorrhage
Distribution
Distributed nationwide across the United States.
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