FDA-Device2015-05-20Class II

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

Handicare USA, Inc.
Hazard

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

Sold states
US Distribution to the states of : FL, CA, NJ, NC and MD.
Affected count
64
Manufactured in
2201 Hangar Pl, Ste 200, Allentown, PA, United States
Products
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1613-2015

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