• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medcare Products Max500 Stand, Total Support

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Medcare Products Max500 Stand, Total Support
see related information
Date Posted November 20, 2013
Recall Status1 Open
Recall Number Z-0370-2014
Recall Event ID 66056
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
Code Information Serial numbers 0109STH0042, 0112STH0085, 0112STH0086, 0112STH0087, 0112STH0089, 0112STH0090, 0112STH0091, 0112STH0092, 1211STH0071, 0207STH0003, 0207STH0004, 0209STH0043, 0211STH0072, 0212STH0093, 0212STH0094, 0212STH0095, 0212STH0096, 0212STH0097, 0212STH0098, 0212STH0099, 0212STH0100, 0308STH0027, 0308STH0028, 0308STH0029, 0308STH0030, 0309STH0044, 0309STH0045, 0309STH0046, 0407STH0005, 0409STH0047, 0507STH0006, 0508STH0031, 0508STH0032, 0510STH0058, 0510STH0059, 0510STH0060, 0511STH0073, 0511STH0074, 0607STH0007, 0608STH0033, 0608STH0034, 0609STH0049, 0610STH0061, 0610STH0062, 0610STH0063, 0610STH0064, 0611STH0075, 0611STH0076, 0611STH0077, 0613STH0113, 0613STH0114, 0613STH0115, 0613STH0116, 0613STH0117, 0613STH0118, 0707STH0008, 0708STH0035, 0708STH0036, 0709STH0050, 0709STH0051, 0710STH0065, 0711STH0078, 0711STH0079, 0711STH0080, 0712STH0101, 0712STH0102, 0712STH0103, 0712STH0104, 0809STH0052, 0809STH0053, 0810STH0066, 0810STH0067, 0810STH0068, 0905STH0001, 0907STH0009, 0908STH0037, 0908STH0038, 0909STH0054, 0909STH0055, 0911STH0081, 0911STH0082, 1006STH0002, 1008STH0039, 1008STH0040, 1008STH0041, 1009STH0056, 1009STH0057, 1012STH0105, 1012STH0106, 1012STH0107, 1012STH0108, 1110STH0069, 1112STH0109, 1112STH0110, 1210STH0070, 1211STH0083, and 1211STH0084.
Recalling Firm/
Manufacturer
Ergosafe Products LLC DBA Prism Medical Services USA
45 Progress Pkwy
Maryland Heights, Missouri 63043-3701
For Additional Information Contact Agustin G. de Parades, P Eng
905-850-9003 Ext. 249
Manufacturer Reason
for Recall
The lift might fail with the labeled 500-lb. load rating.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, Medcare Products, sent an "URGENT FIELD CORRECTIVE ACTIONS" letter dated October 21, 2013 via certified mail on October 30, 2013 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to peel off the boom stickers and serial number label and replace with the new ones supplied; review the revised Manual and dispose of the original; and complete the action report form once the products have been relabeled. Please refer to your Operations Manual or visit our website at www.medcarelifts.com to view the manual online. If we can answer any questions that you may have regarding the testing standards or the relabeling of the products, please do not hesitate to contact us at 1-800-695-4479.
Quantity in Commerce 97 units
Distribution Nationwide distribution.
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.
-
-