Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-0593-2020

Z-0593-2020 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), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - 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: 37613154599296, Lot Numbers 60180374, 60181194

Other recalls by Stryker Instruments Div. of Stryker Corporation

  • Z-1452-2022 Class II — SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002 (June 15, 2022)
  • Z-0431-2021 Class II — Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, singl (October 16, 2020)
  • Z-1807-2020 Class II — Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage (March 26, 2020)
  • Z-1402-2022 Class II — Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG (January 22, 2020)
  • Z-1099-2020 Class II — Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie (January 13, 2020)
  • Z-1098-2020 Class II — Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is (January 13, 2020)
  • Z-1097-2020 Class II — SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The produ (January 13, 2020)
  • Z-0592-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
  • Z-0023-2020 Class II — C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: (July 31, 2019)
  • Z-0024-2020 Class II — C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: (July 31, 2019)