Z-1613-2015 Class II Terminated
FDA device recall Z-1613-2015 was initiated by Handicare USA, Inc. on March 26, 2015 and is designated Class II. Reason for recall: Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied. The recall status is terminated (terminated August 17, 2015). Affected quantity: 64.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2015
- Initiation Date
- March 26, 2015
- Termination Date
- August 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64
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.
Distribution Pattern
US Distribution to the states of : FL, CA, NJ, NC and MD.
Code Information
All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136