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Recall Observatory FDA recall evidence

Device product

ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.

Z-1613-2015

March 26, 2015

Class II

Product summary

Firm
Handicare USA, Inc.
Event
Event 70995
Status
Terminated
Classification
Class II
Quantity
64
Official record key
device-enforcement:Z-1613-2015

Official wording

Reason: Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.

Code information: All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136

Distribution pattern: US Distribution to the states of : FL, CA, NJ, NC and MD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.