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
FDA Recall Z-0630-2014 · Posted 2014-01-06
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeKCY
Date Initiated2013-12-06
Date Terminated2014-02-27
Product Quantity5 boxes (50 units)
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.
Firm Action
Distributor was notified by E-mail 11/26/2013, with follow-up UPS letters sent to Hospital Risk/ Materials Managers identifying the product, reason for the recall, and risk. The notice asked consignees to find and quarantine all implicated product, with hospitals requested to complete the Business Reply Form and FAX to 866-521-2762. Stryker will email a pre-paid shipper and credit all accounts. Question and concerns should be addressed to Kelly Jo Whipple 269-389-2921 or [email protected]
Root Cause
Component change control
Distribution Pattern
US Distribution: including states of: MI, OH, and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.