Events

Recall of Device Recall Flite Clip Slings

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

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
    51273
  • Event Risk Class
    Class 2
  • Event Number
    Z-1637-2009
  • Event Initiated Date
    2009-02-26
  • Event Date Posted
    2009-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79554
  • 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
    Clip Slings - Product Code FSA
  • Reason
    If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.
  • Action
    An "Urgent Field Safety Notification" letter dated January 30, 2009 to all customers with ARJO/BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars via UPS 2nd day on the February 26, 2009. The notification letter informed the accounts of the potential for clip detachments if the sling clips are not applied to the hanger bar attachment lugs. The accounts were instructed to do the following: 1) Apply the stickers provided to the passive patient lift and/or ceiling lift hanger bars as shown in the enclosed Sticker Application Instructions sheet; 2) Retrain lift operators in accordance with the enclosed instructional DVD, the revised Passive Clip Sling Operating and Product Care Instructions manual and the revised Flites Clip Operating and Product Care Instructions manual; and 3) Make lift operators aware of the Clip Sling/ Flites Clip Application Instructional poster and its location within their facility. The accounts were also instructed to complete and fax back to Arjo the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, acknowledging receipt and understanding of the Field Safety Notice. If you have any questions or require any additional information, contact the ARJO, Inc. Quality, Customer Support, or Technical Support Departments via e-mail at quality@arjousa.com, via phone at 1-800-323-1245, or via fax at 1-888-594-2756.

Device

Device Recall Flite Clip Slings
  • Model / Serial
    Model MFA1000M (all slings manufactured prior to March 1, 2009).
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo NV, Heikant 5, 3930 Hamont Achel, Belgium; these slings are intended for use with Arjo and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings. || The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers.
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh
  • Manufacturer Address
    ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA