Events

Recall of Device Recall Color Cuff

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67040
  • Event Risk Class
    Class 2
  • Event Number
    Z-0630-2014
  • Event Initiated Date
    2013-12-06
  • Event Date Posted
    2014-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124590
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Torniquet, pneumatic - Product Code KCY
  • Reason
    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
    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

Device

Device Recall Color Cuff
  • Model / Serial
    Lot 50731155 Color code Purple
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution: including states of: MI, OH, and TX.
  • Product Description
    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
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA