Recall Z-2461-2015— Ferno-Washington Inc
Class II · Terminated
Class II FDA medical device recall by Ferno-Washington Inc, initiated 2015-05-01, terminated 2015-11-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.. 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..
- Recalling firm
- Ferno-Washington Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-01
- Terminated
- 2015-11-06
- Firm location
- Wilmington, OH, United States
Product description
Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.