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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 Initiated by Firm May 10, 2013
Date Posting Updated April 10, 2014
Recall Status1 Terminated 3 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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