Z-0592-2020 Class II Terminated
FDA device recall Z-0592-2020 was initiated by Stryker Instruments Div. Of Stryker Corporation on Nov 6, 2019 and is designated Class II. Reason for recall: There is a potential for the cuff to leak air leading to a loss of vascular occlusion. The recall status is terminated (terminated Nov 19, 2021). Affected quantity: 16,380 total.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 11, 2019
- Initiation Date
- Nov 6, 2019
- Termination Date
- Nov 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0592-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026