Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0171-2014Class II

Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number...

Handicare USA, Inc. / initiated 2012-11-29 / Terminated / root cause: design

Handicare Accessibility began a recall of Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers... on . FDA classified it as Class II and gives the reason as "Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0171-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Handicare USA, Inc.
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.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.
Root cause tag
design
FDA root cause
Device Design
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.
Quantity in commerce
3301 handsets
Distribution
Worldwide distribution: USA (Nationwide) and country of: Canada.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0171-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0171-2014Class IITerminatedVoluntary: Firm initiated