Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-0592-2020

Z-0592-2020 Class II Terminated

Recalled by Stryker Instruments Div. of Stryker Corporation — Portage, MI

Recall Details

Product Type
Devices
Report Date
December 11, 2019
Initiation Date
November 6, 2019
Termination Date
November 19, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,380 total

Product Description

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.

Reason for Recall

There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

Distribution Pattern

Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.

Code Information

GTIN: 37613154599258, Lot Numbers 60180348, 60180373

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  • Z-0593-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
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