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Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog ...

FDA Recall #Z-1341-2023 — Class II — March 1, 2023

Recall #Z-1341-2023 Date: March 1, 2023 Classification: Class II Status: Ongoing

Product Description

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

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

Recalling Firm

Stryker Corporation — Portage, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1979 units (packs of 10)

Distribution

US Nationwide distribution.

Code Information

GTIN: 07613327606171 Lot Numbers: 2022111805 2022112801 2022112803 2022112804 2022112805 2022112806 2022112807 2022112808 2022120506 2022120507 2022120508

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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