Recall Z-0303-2017 ยท IKX Aid, Transfer
Handicare USA, Inc.
ReTurn 7500/7500 Aid, transfer
| Date | Apr 15, 2014 |
| Status | Terminated |
| Reason | During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder. |
| Root cause | Nonconforming Material/Component |
| Action | Handicare sent a Field Safety notice dated April 21, 2014, to all affected customers. The notification instructed customers to examine the affected ReTurn units for signs of wear and to complete the response form that was mailed with the customer notification letter indicating whether additional parts were required to complete the field correction. For further questions, please call (717) 733-1444. |
| Quantity | 29 units , plus 47 wing handles were shipped as spare parts |
| Distribution | US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.