Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Mode

FDA device recall Z-0079-2015 · posted 2014-10-17 · Terminated

Recall details

Recalling firm

Arjo, Inc. dba ArjoHuntleigh

Reason for recall

The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the sling. The loop of the sling could potentially come out of the hooks if positioned in the upper portion of the hooks.

Action taken

URGENT FIELD CORRECTION RECALL letters dated January 21, 2013 were sent to all direct accounts (customers). The letters identified the potential safety related issue; included instructions on how to use the Medium Two Hooks Spreader Bars, and to complete and return the enclosed Customer Response form. Once the Customer Response form has been returned customers will be contacted by an ArjoHuntleigh service representative to make arrangements for the replacement of the existing spreader bars with spreader bars of a different design. Customers with any questions about this recall can contact ArjoHuntleigh by telephone at 800-323-1245, extension 57985, or by e-mail at usa.quality@arjohuntleigh.com.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

363 spreader bars

Distribution

USA Distribution - AR, GA, MI, PA, and the District of Columbia.

Date initiated

2013-01-21

Date posted

2014-10-17

Date terminated

2015-10-27

Location

Addison, IL