Events

Recall of Stryker Secure II hospital bed; model 3002.

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
    26325
  • Event Risk Class
    Class 2
  • Event Number
    Z-0868-03
  • Event Initiated Date
    2003-05-01
  • Event Date Posted
    2003-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27511
  • 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
    Bed, Ac-Powered Adjustable Hospital - Product Code FNL
  • Reason
    A wire may break at the crimp and present a potential electric shock hazard.
  • Action
    The firm sent service representatives to the receiving hospitals, beginning on 5/1/02, and the beds were corrected in place.

Device

Stryker Secure II hospital bed; model 3002.
  • Model / Serial
    serial numbers 030415710, 030415711, 030415712, 030415713, 030415714 and 030415729.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Pennsylvania and Kansas
  • Product Description
    Stryker Secure II hospital bed; model 3002.
  • Manufacturer
    Stryker Medical

Manufacturer

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