Events

Recall of Device Recall Firstcare Ultra or Adel

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
    28135
  • Event Risk Class
    Class 2
  • Event Number
    Z-0526-04
  • Event Initiated Date
    2004-01-26
  • Event Date Posted
    2004-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31311
  • 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
    Table, Obstetrical, Ac-Powered (And Accessories) - Product Code HDD
  • Reason
    A potential shock hazard exists if the night light is damaged.
  • Action
    Recall letters dated January 21, 2003 were sent to each customer advising them of the firm''s plans to make a product field correction.

Device

Device Recall Firstcare Ultra or Adel
  • Model / Serial
    All beds manufactured between January 1, 1997 and December 23, 2003.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Brazil, Canada, Chile, Hong Kong, Korea, Kuwait, Latin America, Mexico, Netherlands, Panama, Singapore, Switzerland, United Arab Emirates and United Kingdom.
  • Product Description
    Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light.
  • Manufacturer
    Stryker Medical

Manufacturer

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