Device product

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

Z-0630-2014

December 06, 2013

Class II

Product summary

Firm: Stryker Instruments Div. of Stryker Corporation
Event: Event 67040
Status: Terminated
Classification: Class II
Quantity: 5 boxes (50 units)
Official record key: device-enforcement:Z-0630-2014

Official wording

Reason: 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.

Code information: Lot 50731155 Color code Purple

Distribution pattern: US Distribution: including states of: MI, OH, and TX.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.