Recall Z-0371-2014 ยท FSA Lift, Patient, Non-Ac-Powered
Ergosafe Products LLC DBA Prism Medical Services USA
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.
| Date | Nov 20, 2013 (initiated Oct 30, 2013) |
| Status | Terminated |
| Reason | The lift might fail with the labeled 500-lb. load rating. |
| Root cause | 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 |
| Quantity | 233 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.