Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Por

FDA device recall Z-0630-2014 · posted 2014-01-06 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

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

Root cause

Component change control

Status

Terminated

Product code

KCY

Quantity affected

5 boxes (50 units)

Distribution

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

Date initiated

2013-12-06

Date posted

2014-01-06

Date terminated

2014-02-27

Location

Portage, MI