Events

Recall of Device Recall Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Sustainability Solutions.

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
    72880
  • Event Risk Class
    Class 2
  • Event Number
    Z-0629-2016
  • Event Initiated Date
    2015-12-17
  • Event Date Posted
    2016-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142400
  • 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
    Tourniquet, pneumatic - Product Code KCY
  • Reason
    Reprocessed stryker pressure tourniquet cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
  • Action
    The firm sent out customer notification letters on 12/17/15. The firm requests that customers discontinue the use of the affected lots of the recall product, and other Pressure Tourniquet Cuffs reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped to the customer is included with the notification. The firm states to complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in inventory. The letter states the form needs to be completed even if no product is found. If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433X5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Device

Device Recall Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs
  • Model / Serial
    Model #5921-218-135 Lot #3490521 Model #5921-034-235 Lot #3531111 Model #5921-034-135 Lot #3733336, 4002152 Model #5921-044-135 Lot #3759409 Model #5921-024-236 Lot #3822485
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.
  • Product Description
    Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs || Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 || Indicated for use in patients who require surgery of the extremities.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Manufacturer Address
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA