Recall Z-2461-2015 ยท FPO Stretcher, Wheeled
Ferno-Washington Inc
Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
| Date | Aug 25, 2015 (initiated May 1, 2015) |
| Status | Terminated |
| Reason | The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use. |
| Root cause | Process control |
| Action | Ferno's first action of May 1, 2015 was to telephone all customers to alert them to the potential issue and explain our planned inspection. Ferno's Technical Support Manager emailed a copy of the Service Notice and iNX Equipment Evaluation Form to the customers as well. |
| Quantity | 26 units |
| Distribution | Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.