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.
Reported: December 11, 2019 Initiated: November 6, 2019 #Z-0592-2020
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.
Details
- Recalling Firm
- Stryker Instruments Div. of Stryker Corporation
- Units Affected
- 16,380 total
- Distribution
- 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.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 16,380 total.
Why was this product recalled? ▼
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2019. Severity: Moderate. Recall number: Z-0592-2020.
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