FDA Recall 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 · Initiated November 29, 2012

Recall

Recall Number: Z-0171-2014
Event Number: 63859
Firm: Handicare Accessibility
FEI Number: 3007802293
Product Code: FSA
Status: Terminated
Root Cause: Device Design
Initiated: November 29, 2012
Posted: November 6, 2013
Terminated: December 8, 2014
Address: 2201 Hangar Place, # 200, Allentown, PA, 18109

Description

Reason

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 [email protected]. For questions regarding this recall call 610-266-5260.

Distribution

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

Quantity

3301 handsets