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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 Device Recall Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handsetsee related information
Date Initiated by FirmNovember 29, 2012
Date PostedNovember 06, 2013
Recall Status1 Terminated 3 on December 08, 2014
Recall NumberZ-0171-2014
Recall Event ID 63859
Product Classification Lift, patient, non-ac-powered - Product Code FSA
ProductHandset 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 PA 18109
Manufacturer Reason
for Recall		Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.
FDA Determined
Cause 2		Device Design
ActionHandicare 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 Commerce3301 handsets
DistributionWorldwide distribution: USA (Nationwide) and country of: Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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