Z-2461-2015Class II

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

Name: Z-2461-2015 Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient...
Creator: Ferno-Washington Inc
Published: 2015-05-01
License: https://open.fda.gov/license/

Ferno-Washington Inc / initiated 2015-05-01 / Terminated / root cause: manufacturing process

FDA source

Ferno-Washington Inc began a recall of Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport on 2015-05-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2461-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-01
Posted: 2015-08-25
Terminated: 2015-11-06
Recalling firm: Ferno-Washington Inc
Product: Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
Product code: FPO Stretcher, Wheeled
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 26 units
Distribution: Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2461-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2461-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-25

Product code FPO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)