Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
FDA device recall Z-2461-2015 · posted 2015-08-25 · Terminated
Recall details
- Recalling firm
- Ferno-Washington Inc
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPO
- Quantity affected
- 26 units
- Distribution
- Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.
- Date initiated
- 2015-05-01
- Date posted
- 2015-08-25
- Date terminated
- 2015-11-06
- Location
- Wilmington, OH
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