Events

Recall of Assist Bed Rail

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare 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
    77128
  • Event Risk Class
    Class 2
  • Event Number
    Z-2218-2017
  • Event Initiated Date
    2017-04-25
  • Event Date Posted
    2017-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155005
  • 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
    unknown device name - Product Code N/A
  • Reason
    A typographical error was noted within the user manual for the 6632 assist bed rail which could result in the assist bed rails being installed incorrectly.
  • Action
    On 4/28/2017 the firm sent Urgent Medical Device Correction letters to their customers.

Device

Assist Bed Rail
  • Model / Serial
    MN: 6632; Date Code begging with FT150701 through FT170228
  • Distribution
    Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.
  • Product Description
    Assist Bed Rail - 6632
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA