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Recall Observatory FDA recall evidence

Device product

Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.

Z-2461-2015

May 01, 2015

Class II

Product summary

Firm
Ferno-Washington Inc
Event
Event 71556
Status
Terminated
Classification
Class II
Quantity
26 units
Official record key
device-enforcement:Z-2461-2015

Official wording

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.

Code information: Serial numbers: 15F001703, 15F001704, 15F001705, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001714, 15F001715, 15F001716, 15F001717, 15F001719, 15F001720, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001729 & 15F001730.

Distribution pattern: Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.