Stryker Color Cuff Tourniquet Cuff pressure failure recall
Stryker is recalling 1,730 units of Color Cuff Non-Sterile Tourniquet Cuffs due to failures in achieving and maintaining pressure during setup, which could result in operative site blood loss 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 significant risk of harm (hemorrhage during surgery) from pressure failure, but no reported hospitalizations or injuries documented in the source. Fits the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Stryker Corporation is recalling 1,730 units of Color Cuff Non-Sterile Disposable Tourniquet Cuff (catalog number 5921-218-135NS) that were distributed nationwide in the United States.
The recalled tourniquet cuffs may fail to achieve the desired pressure or fail to maintain pressure during initial setup. Two different underlying causes have been identified as responsible for these failures.
These pressure failures can occur during the initial setup phase and may lead to operative site blood loss, hemorrhage, or in exceedingly rare situations, other major complications.
The affected lot numbers are 2022111801, 2022112903, 2022121201, 2022121202, 2022121203, 2022121204, 2022121205, and 2022121206.
The recalled product
- Product
- Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
- Manufacturer
- Stryker Corporation
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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