Events

Recall of EZPro

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

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
    29864
  • Event Risk Class
    Class 2
  • Event Number
    Z-0023-05
  • Event Initiated Date
    2004-08-17
  • Event Date Posted
    2004-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34686
  • 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
    Stretcher, Wheeled - Product Code FPO
  • Reason
    Locking pins may be installed backward, and cot may drop from highest to lowest position when the users are not prepared for the drop.
  • Action
    Service representatives visited each customer, inspected the cots, and reinstalled the lock pins, if required, beginning on August 10, 2004.

Device

EZPro
  • Model / Serial
    Serial numbers 040639739, 040639849, 040639737, 040639738, 040639675, 040639674, 040639670, 040639671, 040639672, 040639716, 040639847, 040639848, 040639935, 040639936 and 040639937.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Alabama, California, Florida, Kansas, Montana, Oklahoma, Texas and Virginia.
  • Product Description
    Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
  • Manufacturer
    Stryker Medical

Manufacturer

Stryker Medical
  • Manufacturer Address
    Stryker Medical, 6300 Sprinkle Rd, Kalamazoo MI 49001
  • Source
    USFDA