Recall Z-0171-2014 ยท FSA Lift, Patient, Non-Ac-Powered
Handicare Accessibility
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 sec
| Date | Nov 6, 2013 (initiated Nov 29, 2012) |
| Status | Terminated |
| Reason | Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub. |
| 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 Customerservice.usa@handicare.com. For questions regarding this recall call 610-266-5260. |
| Quantity | 3301 handsets |
| Distribution | Worldwide distribution: USA (Nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.