FDA Recall Terminated

Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.

Recall: Z-0079-2015 · Initiated January 21, 2013

Recall

Recall Number
Z-0079-2015
Event Number
63897
Firm
Arjo, Inc. dba ArjoHuntleigh
FEI Number
1419652
Product Code
FSA
Status
Terminated
Root Cause
Device Design
Initiated
January 21, 2013
Posted
October 17, 2014
Terminated
October 27, 2015
Address
2349 W Lake St, Addison, IL, 60101-6183

Description

Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.

Reason

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

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 [email protected].

Distribution

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

Quantity

363 spreader bars