FDA-Device2014-01-15Class II
Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE
Stryker Instruments Div. of Stryker Corporation
Hazard
The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to an inoperable system due to incompatibility with the Smart Pump.
Sold states
US Distribution: including states of: MI, OH, and TX.
Affected count
5 boxes (50 units)
Manufactured in
4100 E Milham Ave, Portage, MI, United States
Products
Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0630-2014Don't want to check this manually?
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