Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), ...
FDA Recall #Z-0171-2014 — Class II — November 29, 2012
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.
Reason for Recall
Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.
Recalling Firm
Handicare Accessibility — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3301 handsets
Distribution
Worldwide distribution: USA (Nationwide) and country of: Canada.
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated