Medical device recalls Moderate risk

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

Recall date
March 26, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1613-2015
FDA classification
Class II
Brand / firm
Handicare USA, Inc.
Sold / distributed
US Distribution to the states of : FL, CA, NJ, NC and MD.

Why it was recalled

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

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

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