Medical device recalls Moderate risk

Handicare USA, Inc. recalls ReTurn 7500/7500 Aid, transfer

Recall date
April 15, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0303-2017
FDA classification
Class II
Brand / firm
Handicare USA, Inc.
Sold / distributed
US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME

Why it was recalled

During the period of April 2009  May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ReTurn 7500/7500 Aid, transfer

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