Recall Z-1450-2014 ยท FSA Lift, Patient, Non-Ac-Powered
ErgoSafe Product LLC dba Prism Medical Services
400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.
| Date | Apr 10, 2014 (initiated May 10, 2013) |
| Status | Terminated |
| Reason | MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to 11/7/2012 do not meet MedCare's high standards. The original design includes a pin that over time and years of use may stop performing as designed and may break. |
| Root cause | Nonconforming Material/Component |
| Action | Medcare sent a Notification letter dated May 10th, 2013 to affected customers. The letter described the affected product, problem, actions to be taken and provided a replacement assembly. It instructed consignees to replace the old assembly with the new one included in the package. For questions they can contact Todd Perrine in their Technical Support Department at 952-300-2101. |
| Quantity | 514 |
| Distribution | USA Nationwide Distribution in the states of: CA, CO, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, NO, NE,NH,NY, ND,OH, OK, OR, PA , SD, TX, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.