Reported Dec 11, 2019 · Terminated
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect…
Stryker Instruments Div. of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
Color Cuff Disposable Tourniquet Cuff18 inch X 3 inch1BLA (Single Bladder)1PRT(Single Port) Quick Connect ConnectorProduct
- Number 5921-018-135 - Product UsageThe 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
- Lot codes and dates
- GTIN
37613154599258Lot Numbers 6018034860180373
- GTIN
- Amount recalled
- 16,380 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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