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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Event Detail

Event ID 63859
Product Type Devices
Status Ongoing
Recalling Firm Handicare Accessibility
City Allentown
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-29
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: USA (Nationwide) and country of: Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub. 3301 handsets Z-0171-2014
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