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U.S. Department of Health and Human Services

Class 2 Device Recall Medcare Lift with Scale Medcare Lift w/Scale 600 lb Scale Hanger Assembly

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 Class 2 Device Recall Medcare Lift with Scale Medcare Lift w/Scale 600 lb Scale Hanger Assembly see related information
Date Posted April 10, 2014
Recall Status1 Terminated on November 20, 2014
Recall Number Z-1450-2014
Recall Event ID 67804
Product Classification Lift, patient, non-ac-powered - Product Code FSA
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.
Code Information 163400
21134899
21173085
21153494
21163438
21173109
21189283
21189286
21134911
21134897
21163408
21153554
21153560
21153520
21134907
21134916
21153512
21189284
21189293
21153481
21153530
21173080
21226274
21226285
21153479
21153524
21226278
21226275
21233710
21153511
21173075
21153548
21153508
21134903
21134920
21233715
21134910
21233717
21233723
21226273
21134917

Recalling Firm/
Manufacturer
ErgoSafe Product LLC dba Prism Medical Services
480 University Avenue, Suite 510
Toronto, ON Canada M5GiV2
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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