Z-0630-2014Class II

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

Name: Z-0630-2014 Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2013-12-06
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-12-06 / Terminated / root cause: sterility

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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 on 2013-12-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0630-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-06
Posted: 2014-01-06
Terminated: 2014-02-27
Recalling firm: Stryker Corp.
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
Product code: KCY Tourniquet, Pneumatic
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.
Root cause tag: sterility
FDA root cause: Component change control
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]
Quantity in commerce: 5 boxes (50 units)
Distribution: US Distribution: including states of: MI, OH, and TX.
Product codes and lots: Lot 50731155 Color code Purple

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0630-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0630-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-06

Product code KCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)