Events

Recall of ReTurn 7400/7500

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Handicare USA, 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
    75404
  • Event Risk Class
    Class 2
  • Event Number
    Z-0303-2017
  • Event Initiated Date
    2014-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150211
  • 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
    Aid, transfer - Product Code IKX
  • Reason
    During the period of april 2009  may 2011, handicare ab used a wing handle in which the screw and handle, after repeated tightening, may slide apart. this causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. eventually, this may cause mechanical fatigue in the material of the ladder.
  • Action
    Handicare sent a Field Safety notice dated April 21, 2014, to all affected customers. The notification instructed customers to examine the affected ReTurn units for signs of wear and to complete the response form that was mailed with the customer notification letter indicating whether additional parts were required to complete the field correction. For further questions, please call (717) 733-1444.

Device

ReTurn 7400/7500
  • Model / Serial
    Model # 7400, 7500 and 7322 (spare part) Serial # 373317697270501334, 373317697270501430, 073317697400500012, 073317697400500057
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME
  • Product Description
    ReTurn 7500/7500 || Aid, transfer
  • Manufacturer
    Handicare USA, Inc.

Manufacturer

Handicare USA, Inc.
  • Manufacturer Address
    Handicare USA, Inc., 2201 Hangar Pl, Ste 200, Allentown PA 18109-9342
  • Manufacturer Parent Company (2017)
    Handicare Group Ab
  • Source
    USFDA