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.
FDA Recall Z-0079-2015 · Posted 2014-10-17
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Recalling FirmArjo, Inc. dba ArjoHuntleigh
Recall StatusTerminated
Product CodeFSA
Date Initiated2013-01-21
Date Terminated2015-10-27
Product Quantity363 spreader bars
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.
Firm 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].
Root Cause
Device Design
Distribution Pattern
USA Distribution - AR, GA, MI, PA, and the District of Columbia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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