FDA Enforcement Class II Terminated

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.

Recall: Z-0171-2014 · Reported November 13, 2013

Enforcement

Recall Number
Z-0171-2014
Event ID
63859
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Handicare Accessibility
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
November 13, 2013
Initiation Date
November 29, 2012
Classification Date
November 6, 2013
Termination Date
December 8, 2014
Address
2201 Hangar Place, #200, Allentown, PA, 18109, United States

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.

Reason

Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.

Code Info

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.

Distribution

Worldwide distribution: USA (Nationwide) and country of: Canada.

Quantity

3301 handsets