The Recall Desk
HighFDA (Devices)·Z-2461-2015·Announced 2015-09-02

Ferno iNX Wheeled Stretcher Wheel Caster Set Screw Recall

Ferno-Washington Inc is recalling 26 Ferno iNX Wheeled Stretchers due to improperly installed wheel caster set screws that may allow bearing cups to back out.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for patient transport where a mechanical failure could lead to injury, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Ferno-Washington Inc is recalling 26 units of the Ferno iNX Wheeled Stretcher for pre-hospital patient transport. The recall was initiated after the firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. This screw is designed to assist in preventing the bearing cup on the caster assembly from backing out of the caster arm during use.

The affected units were distributed in the states of Arizona, Colorado, Iowa, Maryland, Ohio, Pennsylvania, and Washington, as well as in Australia, Canada, and the United Kingdom. The specific serial numbers for the recalled units are 15F001703 through 15F001730, excluding 15F001718 and 15F001728.

Consumers and healthcare facilities should check their inventory for these specific serial numbers. If a unit is found, it should be removed from service and the firm contacted for instructions on repair or replacement.

The recalled product

Product
Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
Affected units
26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers: 15F001703
  • 15F001704
  • 15F001705
  • 15F001706
  • 15F001707
  • 15F001708
  • 15F001709
  • 15F001710
  • 15F001711
  • 15F001712
  • 15F001713
  • 15F001714
  • 15F001715
  • 15F001716
  • 15F001717
  • 15F001719
  • 15F001720
  • 15F001721
  • 15F001722
  • 15F001723

Distribution

Distributed in 7 states: