Recall Z-0630-2014
Stryker Instruments Div. of Stryker Corporation · initiated December 6, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot 50731155 Color code Purple
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.
FDA-determined cause: Component change control
Action taken
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
Details
- Recall number
- Z-0630-2014
- Initiated
- December 6, 2013
- Posted by FDA
- January 6, 2014
- Terminated
- February 27, 2014
- Product code
- KCY – Tourniquet, Pneumatic
- Quantity
- 5 boxes (50 units)
- Distribution
- US Distribution: including states of: MI, OH, and TX.
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Portage, MI