FDA-Device2014-10-22Class II

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.

Arjo, Inc. dba ArjoHuntleigh
Hazard

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.

Sold states
USA Distribution - AR, GA, MI, PA, and the District of Columbia.
Affected count
363 spreader bars
Manufactured in
2349 W Lake St, N/A, Addison, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0079-2015

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