FDA-Device2016-11-02Class II
ReTurn 7500/7500 Aid, transfer
Handicare USA, Inc.
Hazard
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.
Sold states
US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME
Affected count
29 units , plus 47 wing handles were shipped as spare parts
Manufactured in
2201 Hangar Pl, Ste 200, Allentown, PA, United States
Products
ReTurn 7500/7500 Aid, transfer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0303-2017Don't want to check this manually?
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