Events

Recall of Device Recall Stryker Renaissance Series Stretchers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical 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
    55139
  • Event Risk Class
    Class 2
  • Event Number
    Z-2185-2010
  • Event Initiated Date
    2010-03-19
  • Event Date Posted
    2010-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90004
  • 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
    Powered Wheeled Stretcher - Product Code INK
  • Reason
    The retractable cord stretchers were fitted with power cords, manufactured by electri-cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
  • Action
    The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.

Device

Device Recall Stryker Renaissance Series Stretchers
  • Model / Serial
    Model 1231: 39 Units 0310049178, 0310049179, 0311058120, 0312050809, 0407059532, 0407059533, 0407059656, 0407059657, 0407059851, 0407059852, 0407059853, 0407059854, 0407059855, 0407059856, 0407059857, 0407059858, 0407059859, 0407059860, 0407059861, 0407059862, 0407059863, 0407059864, 0407059865, 0407059866, 0407059867, 0407059868, 0407059869, 0407059870, 0408059073, 0408059123, 0408059124, 0408059871, 0408059872, 0408059873, 0408059874, 0408059875, 0408059876, 0408059877, and 0409062555.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
  • Product Description
    Stryker Renaissance Series Stretchers, Model 1231Z Emergency Care with Zoom, Stryker Medical, Portage, MI.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA