Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Ope

FDA device recall Z-0370-2014 · posted 2013-11-20 · Terminated

Recall details

Recalling firm

Ergosafe Products LLC DBA Prism Medical Services USA

Reason for recall

The lift might fail with the labeled 500-lb. load rating.

Action taken

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

Status

Terminated

Product code

FSA

Quantity affected

97 units

Distribution

Nationwide distribution.

Date initiated

2013-10-30

Date posted

2013-11-20

Date terminated

2017-05-17

Location

Maryland Heights, MO