FDA-Device2023-04-12Class II
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
Stryker Corporation
Hazard
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
Sold states
US Nationwide distribution.
Affected count
1979 units (packs of 10)
Manufactured in
1941 Stryker Way, Portage, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1341-2023Don't want to check this manually?
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