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Recall Observatory FDA recall evidence

Device product

ReTurn 7500/7500 Aid, transfer

Z-0303-2017

April 15, 2014

Class II

Product summary

Firm
Handicare USA, Inc.
Event
Event 75404
Status
Terminated
Classification
Class II
Quantity
29 units , plus 47 wing handles were shipped as spare parts
Official record key
device-enforcement:Z-0303-2017

Official wording

Reason: 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.

Code information: Model # 7400, 7500 and 7322 (spare part) Serial # 373317697270501334, 373317697270501430, 073317697400500012, 073317697400500057

Distribution pattern: US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.