FDAFDA · Food and drugs·Recall number Z-0630-2014
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
Published January 15, 2014 · Recall initiated: December 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- US Distribution: including states of: MI, OH, and TX.
- Lot
- Lot 50731155 Color code Purple
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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