—#124590

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

FDA product code: KCY — Tourniquet, Pneumatic
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot 50731155 Color code Purple

Why it was recalled

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.

Root cause (FDA determination)

Component change control

Action the firm took

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 kellyjo.whipple@stryker.com

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

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

Timeline

Recall initiated: 2013-12-06
Posted by FDA: 2014-01-06
Terminated: 2014-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124590. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.