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U.S. Department of Health and Human Services

Class 2 Device Recall Medcare Products Max500 Stand, Total Support

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  Class 2 Device Recall Medcare Products Max500 Stand, Total Support see related information
Date Initiated by Firm October 30, 2013
Date Posted November 20, 2013
Recall Status1 Open3, Classified
Recall Number Z-0371-2014
Recall Event ID 66056
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. 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 0106SWH0008, 0106SWH0009, 0106SWH0010, 0107SWH0031, 0107SWH0032, 0107SWH0033, 0107SWH0034, 0108SWH0044, 0108SWH0045, 0109SWH0065, 0109SWH0066, 0109SWH0067, 0109SWH0068, 0109SWH0069, 0109SWH0070

0109SWH0071, 0111SWH0148, 0111SWH0149, 0111SWH0150

0111SWH0151, 0112SWH0199, 0112SWH0200, 0112SWH0201, 0112SWH0202, 0112SWH0203, 0112SWH0204, 0206SWH0011, 0206SWH0012, 0209SWH0072, 0209SWH0073, 0209SWH0074, 0209SWH0075, 0209SWH0076, 0209SWH0077, 0209SWH0078, 0209SWH0079, 0211SWH0152, 0211SWH0153, 0211SWH0154, 0211SWH0155, 0211SWH0156, 0212SWH0210, 0212SWH0205, 0212SWH0206, 0212SWH0207, 0212SWH0208, 0212SWH0209, 0307SWH0035, 0308SWH0046, 0308SWH0047, 0309SWH0080, 0309SWH0081, 0309SWH0082, 0311SWH0157, 0311SWH0158, 0312SWH0211, 0312SWH0212, 0312SWH0213, 0312SWH0214, 0313SWH0234, 0313SWH0235, 0313SWH0236, 0408SWH0048, 0409SWH0083, 0409SWH0084, 0409SWH0085, 0409SWH0086, 0409SWH0087, 0409SWH0088, 0409SWH0089, 0409SWH0090, 0409SWH0091, 0409SWH0092, 0409SWH0093, 0409SWH0094, 0409SWH0095, 0409SWH0096, 0409SWH0097, 0409SWH0098, 0409SWH0099, 0411SWH0159, 0411SWH0161, 0412SWH0215

0412SWH0216, 0507SWH0036, 0507SWH0037, 0507SWH0038, 0507SWH0039, 0508SWH0050, 0510SWH0118, 0510SWH0119, 0510SWH0120, 0510SWH0121, 0511SWH0162, 0511SWH0163, 0511SWH0164, 0512SWH0217, 0512SWH0218, 0512SWH0219, 0512SWH0220, 0512SWH0221, 0512SWH0222, 0613SWH0237, 0613SWH0238, 0613SWH0239, 0613SWH0240, 0613SWH0241, 0613SWH0242, 0613SWH0243, 0613SWH0244, 0613SWH0245, 0613SWH0246, 0613SWH0247, 0613SWH0248, 0613SWH0249, 0613SWH0250, 0708SWH0052, 0708SWH0053, 0709SWH0100, 0710SWH0122, 0710SWH0123, 0711SWH0165, 0711SWH0166, 0711SWH0167, 0711SWH0168, 0711SWH0169, 0711SWH0170, 0712SWH0223, 0712SWH0224, 0712SWH0225, 0805SWH0001, 0805SWH0002, 0805SWH0003, 0805SWH0004, 0806SWH0013, 0806SWH0014, 0806SWH0015, 0806SWH0016, 0808SWH0054, 0808SWH0055, 0808SWH0056, 0809SWH0101, 0810SWH0124, 0810SWH0125, 0810SWH0126, 0810SWH0127, 0812SWH0226, 0812SWH0227, 0812SWH0228, 0906SWH0017, 0907SWH0040, 0908SWH0057, 0908SWH0058, 0908SWH0059, 0908SWH0060

0908SWH0061, 0908SWH0062, 0910SWH0128, 0910SWH0129, 0910SWH0130, 0910SWH0131, 0910SWH0132, 0910SWH0133, 0910SWH0134, 0910SWH0135, 0910SWH0136, 0910SWH0137, 0910SWH0138, 0910SWH0139, 0911SWH0171, 0911SWH0172, 0911SWH0173, 0911SWH0174, 0911SWH0175, 0911SWH0176, 0911SWH0177, 0911SWH0178, 0911SWH0179, 0911SWH0180, 0911SWH0181, 0911SWH0182, 0911SWH0183, 0911SWH0184, 1006SWH0018, 1006SWH0019, 1006SWH0020, 1006SWH0021, 1006SWH0022, 1006SWH0023, 1006SWH0024, 1007SWH0041, 1007SWH0042, 1007SWH0043, 1009SWH0102, 1009SWH0103, 1009SWH0104, 1009SWH0105, 1009SWH0106, 1009SWH0107

1009SWH0108, 1009SWH0109, 1009SWH0110, 1009SWH0111

1009SWH0112, 1009SWH0113, 1009SWH0114, 1011SWH0185, 1012SWH0229, 1012SWH0230, 1012SWH0231, 1012SWH0232, 1106SWH0025, 1106SWH0026, 1106SWH0027, 1106SWH0028, 1106SWH0029, 1106SWH0030, 1108SWH0063, 1108SWH0064, 1109SWH0115, 1110SWH0140, 1110SWH0141, 1111SWH0195, 1205SWH0005, 1205SWH0006, 1205SWH0007, 1209SWH0116, 1209SWH0117, 1210SWH0142, 1210SWH0144, 1210SWH0145, 1210SWH0146, and 1210SWH0147
Recalling Firm/
Manufacturer
Ergosafe Products LLC DBA Prism Medical Services USA
45 Progress Pkwy
Maryland Heights MO 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
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 233 units
Distribution Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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