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FDA (Device enforcement)Recalled 2023-03-01class ii

Stryker Corporation: 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 te

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

Details from the source

Reason for recall: 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 Distribution: US Nationwide distribution. Quantity: 1979 units (packs of 10) Lot/code info: GTIN: 07613327606171 Lot Numbers: 2022111805 2022112801 2022112803 2022112804 2022112805 2022112806 2022112807 2022112808 2022120506 2022120507 2022120508

UPC codes

07613327606171

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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