Events

Recall of Hill-Rom Newborn bassinet; model P248.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom, Inc..

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
    27950
  • Event Risk Class
    Class 2
  • Event Number
    Z-0303-04
  • Event Initiated Date
    2003-12-19
  • Event Date Posted
    2004-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30789
  • 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, Pediatric Open Hospital - Product Code FMS
  • Reason
    The caster/wheel may come off of the bassinet, causing the bassinet to tip.
  • Action
    Recall letters dated December 19, 2003 were sent to each customer. Customers were instructed to verify the security of the casters to the base, and to visually check for loose or missing caster screws until Hill-Rom can visit each facility and perform a fix.

Device

Hill-Rom Newborn bassinet; model P248.
  • Model / Serial
    All units distributed between May 1989 and March 2001.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Australia, Canada, China, France, Germany, Honduras, Israel, Japan, Mexico, Panama, Taiwan, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    Hill-Rom Newborn bassinet; model P248.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 125 E Pearl St, Batesville IN 47006
  • Source
    USFDA