Stryker Tourniquet Cuff Pressure Failure May Lead to Blood Loss
Stryker's non-sterile disposable tourniquet cuff may fail to achieve or maintain proper pressure during surgical setup, potentially causing blood loss or hemorrhage. Approximately 1,979 units distributed nationwide are affected.
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 FDA Class II recall involves a surgical medical device with potential to cause serious harm through blood loss or hemorrhage if the pressure-failure defect occurs. No actual injuries or illnesses have been reported in the source text, placing it in the High severity category as a risk-of-harm product without reported injury.
Plain-English summary
Stryker Corporation is recalling its Color Cuff Non-Sterile Disposable Tourniquet Cuff (Catalog number 5921-034-135NS) due to a pressure-failure defect. The affected cuffs were distributed nationwide.
The device may fail to achieve the desired pressure or may not hold pressure once set during initial placement on the patient. This failure can result in operative site blood loss, hemorrhage, or in exceedingly rare cases, other major complications.
The recall affects 1,979 units (packs of 10). Affected units can be identified by catalog number 5921-034-135NS and the following lot numbers: 2022111805, 2022112801, 2022112803, 2022112804, 2022112805, 2022112806, 2022112807, 2022112808, 2022120506, 2022120507, 2022120508.
Healthcare facilities should verify their inventory and take appropriate action by contacting Stryker Corporation or referring to FDA recall Z-1341-2023 for further instructions.
The recalled product
- 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
- Manufacturer
- Stryker Corporation
- Hazard
- pressure-failure
- blood-loss
- hemorrhage
Distribution
Distributed nationwide across the United States.
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