Recall Z-1613-2015— Handicare USA, Inc.

Name: FDA recall Z-1613-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-26

Class II · Terminated

Class II FDA medical device recall by Handicare USA, Inc., initiated 2015-03-26, terminated 2015-08-17. FDA's recall record names no specific 510(k) clearance for this event. Product: ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.. Reason: Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied..

Recalling firm: Handicare USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-26
Terminated: 2015-08-17
Firm location: Allentown, PA, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.