Recall Z-0303-2017

Handicare USA, Inc. · initiated April 15, 2014

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

ReTurn 7500/7500 Aid, transfer

Codes / lots: Model # 7400, 7500 and 7322 (spare part) Serial # 373317697270501334, 373317697270501430, 073317697400500012, 073317697400500057

Reason for recall

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.

FDA-determined cause: Nonconforming Material/Component

Action taken

Handicare sent a Field Safety notice dated April 21, 2014, to all affected customers. The notification instructed customers to examine the affected ReTurn units for signs of wear and to complete the response form that was mailed with the customer notification letter indicating whether additional parts were required to complete the field correction. For further questions, please call (717) 733-1444.

Details

Recall number
Z-0303-2017
Initiated
April 15, 2014
Terminated
December 13, 2016
Product code
IKX – Aid, Transfer
Quantity
29 units , plus 47 wing handles were shipped as spare parts
Distribution
US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME
Recalling firm
Handicare USA, Inc., Allentown, PA

Official FDA recall record