Events

Recall of Device Recall Re Turn

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
    70995
  • Event Risk Class
    Class 2
  • Event Number
    Z-1613-2015
  • Event Initiated Date
    2015-03-26
  • Event Date Posted
    2015-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135822
  • 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
    Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
  • Action
    Handicare sent an Voluntary Product Recall Notification letter dated April 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to quarantine any remaining stock and to contact customers if product was further distributed and to return the affected product for a replacement and/or full refund. Also, enclosed is a response form. Please complete and return the form even if you do not have any product to return. Your Sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information (required by FDA). Thank you for your support. We are committed to re-releasing the wipeable ReTurn belt as soon as we believe that it meets the quality standards that you expect from Handicare. Please contact our Customer Experience team at 1-866-276-5438 if you have any questions regarding the recall or would like assistance with the recall. We regret any inconvenience that this action may cause, but we appreciate your understanding as we take action to ensure patient and customer satisfaction.

Device

Device Recall Re Turn
  • Model / Serial
    All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : FL, CA, NJ, NC and MD.
  • Product Description
    ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
  • 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