Device product
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.
Z-0592-2020
Product summary
- Event
- Event 84316
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,380 total
- Official record key
device-enforcement:Z-0592-2020
Official wording
Reason: There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Code information: GTIN: 37613154599258, Lot Numbers 60180348, 60180373
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.
Derived failure modes
-
Unknown
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.