Events

Recall of Device Recall BHM Reacher for Portable Ceiling Lifts

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arjo, 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
    36802
  • Event Risk Class
    Class 2
  • Event Number
    Z-0482-2007
  • Event Initiated Date
    2006-11-13
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49378
  • 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
    patient lift accessory - Product Code FSA
  • Reason
    The carabineer may not be correctly attached to the reacher and the portable patient lift may drop.
  • Action
    BHM sent recall letters to Arjo''s direct accounts on 11/13/06 via first class mail, informing them that fastening the carabineer to the exterior of the closed ring portion of the reacher is contrary to the manufacturer''s instructions and is an unsafe practice. The letters informed the users that Health Canada had received notification of an incident involving a reacher marketed by a competitor, and had conducted an investigation into all similar reachers available on the Canadian market. Enclosed with the letter was a copy of the BHM Reacher User''s Guide as well as a warning sticker that visually describes the safe method for connecting the carabineer to the reacher. The accounts were requested to place the warning stickers on their reachers, review the enclosed User''s Guide in detail, and ensure that all personnel using the reacher receive refresher training on its proper use and have access to the supplied User''s Guide. Once these measures have been completed, the account was requested to complete the enclosed response form and return it to BHM by fax, e-mail or mail.

Device

Device Recall BHM Reacher for Portable Ceiling Lifts
  • Model / Serial
    Part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length, all reachers shipped between November 2003 through November 6, 2006.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The reacher comes in two models: part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Manufacturer Address
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA