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.
FDA Recall Z-0370-2014 · Posted 2013-11-20
Advertisement
Recalling FirmErgosafe Products LLC DBA Prism Medical Services USA
Recall StatusTerminated
Product CodeFSA
Date Initiated2013-10-30
Date Terminated2017-05-17
Product Quantity97 units
Reason for Recall
The lift might fail with the labeled 500-lb. load rating.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement