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Terminated

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

FDA Recall Z-2461-2015 · Posted 2015-08-25

Recalling FirmFerno-Washington Inc
Recall StatusTerminated
Product CodeFPO
Date Initiated2015-05-01
Date Terminated2015-11-06
Product Quantity26 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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