Events

Recall of Device Recall Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handset

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

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
    63859
  • Event Risk Class
    Class 2
  • Event Number
    Z-0171-2014
  • Event Initiated Date
    2012-11-29
  • Event Date Posted
    2013-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114924
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • Reason
    Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.
  • Action
    Handicare sent an Urgent Medical Device Recall letter dated November 29, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately advise all of their customers affected by the recall letter to immediately remove all affected product from use. Upon receipt of affected product, replacement handsets would be sent to customers. Customers with questions were instructed to call 866-276-5438 or email Customerservice.usa@handicare.com. For questions regarding this recall call 610-266-5260.

Device

Device Recall Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handset
  • Model / Serial
    Handsets shipped with Bath Lifts belonging to the following serial numbers: BH05100001 - BH05129999 and BH06120001 - BH11129999; Handsets shipped as spare parts with the following serial numbers: BS05100001 - BS05129999 and BS06120001 - BS11129999.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and country of: Canada.
  • Product Description
    Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) || Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift consisting of a motorized actuator, powered mechanical seating device, temporarily secured in a bath, and used to lift and lower a patient in the vertical or reclining position while bathing.
  • Manufacturer
    Handicare Accessibility

Manufacturer

Handicare Accessibility
  • Manufacturer Address
    Handicare Accessibility, 2201 Hangar Place, #200, Allentown PA 18109
  • Manufacturer Parent Company (2017)
    Handicare Group Ab
  • Source
    USFDA