Device product
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
Z-1613-2015
Product summary
- 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
Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.