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U.S. Department of Health and Human Services

Class 2 Device Recall Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handset

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 Class 2 Recall
Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handset
see related information
Date Posted November 06, 2013
Recall Status1 Open
Recall Number Z-0171-2014
Recall Event ID 63859
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product 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.
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.
Recalling Firm/
Manufacturer
Handicare Accessibility
2201 Hangar Place
#200
Allentown, Pennsylvania 18109
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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.
Quantity in Commerce 3301 handsets
Distribution Worldwide distribution: USA (Nationwide) and country of: Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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