Events

Recall of Hill-Rom Newborn bassinet; model P247

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
    26586
  • Event Risk Class
    Class 2
  • Event Number
    Z-1027-03
  • Event Initiated Date
    2003-06-20
  • Event Date Posted
    2003-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27936
  • 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
  • Reason
    The caster/wheel may come off of the bassinet, causing the bassinet to tip.
  • Action
    Customer notification letters dated June 20, 2003 were sent to each customer. Customers are asked to verify the security of the casters to the base and to visually check for loose or missing caster screws, to remove any bassinets from service until repaired, and that Hill-Rom will visit each customer to replace the caster screws on all units.

Device

Hill-Rom Newborn bassinet; model P247
  • Model / Serial
    All units distributed from November 2000 through April 2003.
  • Distribution
    United States, Brazil, Canada, China, Italy, Japan, Kuwait Netherlands, Qatar, United Kingdom
  • Product Description
    Hill-Rom Newborn bassinet; model P247
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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