Recall Z-1450-2014— ErgoSafe Product LLC dba Prism Medical Services
Class II · Terminated
Class II FDA medical device recall by ErgoSafe Product LLC dba Prism Medical Services, initiated 2013-05-10, terminated 2014-11-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- ErgoSafe Product LLC dba Prism Medical Services
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-10
- Terminated
- 2014-11-20
- Firm location
- Toronto, ON, N/A, Canada
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.