Recall Z-0630-2014— Stryker Instruments Div. of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2013-12-06, terminated 2014-02-27. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-06
- Terminated
- 2014-02-27
- Firm location
- Portage, MI, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.