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

Stryker Corporation: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS 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: 1225 units (packs of 10) Lot/code info: GTIN: 07613327606157 Lot Numbers; 2022111803 2022112901 2022121911 2022121912 2022122601 2022122602

UPC codes

07613327606157

Source

Official record: FDA (Device enforcement)

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

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