Events

Recall of BHM Kwiktrak Fixed Gate

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
    36636
  • Event Risk Class
    Class 2
  • Event Number
    Z-0479-2007
  • Event Initiated Date
    2006-10-23
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49038
  • 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 component - Product Code FSA
  • Reason
    The kwiktrak gate stopper may fail and allow the ceiling lift to pass through to the end of the track and fall to the floor.
  • Action
    Arjo Inc. USA sent recall letters to the direct accounts on 10/30/06, informing them that if the ceiling lift is moved too fast or too forcefully into a closed gate, the gate stopper can be damaged, causing its function to fail. One consequence can be that the gate may remain open, allowing the ceiling lift to pass through to the end of the track. The letters requested the customer to visually inspect their Kwiktrak Gate installation used with their Maxisky-600 Ceiling Lift to determine if there are any signs of impact or burr marks on the closed gate stopper. Illustrations of a damaged and normal gate stopper were included. The customers were requested to stop use of the Kwiktrak track system if any signs of impact or burr marks are found, and contact the Arjo Quality Department at 1-800-323-1245, ext. 6140 for special instructions. If no signs of damage were found, the customers were reminded to make sure that they manually drive the ceiling lift in a gentler manner to prevent damage to the gate stopper, making sure that all personnel using the ceiling lifts are properly trained. The accounts were informed that Arjo personnel will contact them in the next few weeks to install an improved system that will eliminate the risks of failure.

Device

BHM Kwiktrak Fixed Gate
  • Model / Serial
    Part #700.11550 installed in combination with part #700.15515.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Michigan, Ohio and Illinois
  • Product Description
    BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. || The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and || b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits
  • Manufacturer
    Arjo, Inc.

Manufacturer

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