Z-0995-2015Class II

Ferno Model 35X PROFlexx Stretchers, one unit per package

Name: Z-0995-2015 Ferno Model 35X PROFlexx Stretchers, one unit per package
Creator: Ferno-Washington Inc
Published: 2014-12-03
License: https://open.fda.gov/license/

Ferno-Washington Inc / initiated 2014-12-03 / Terminated

FDA source

Ferno-Washington Inc began a recall of Ferno Model 35X PROFlexx Stretchers, one unit per package on 2014-12-03. FDA classified it as Class II and gives the reason as "The wheel castor assemblies may be loosening on the stretchers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0995-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-03
Posted: 2015-01-16
Terminated: 2015-12-01
Recalling firm: Ferno-Washington Inc
Product: Ferno Model 35X PROFlexx Stretchers, one unit per package
Product code: FPO Stretcher, Wheeled
Reason for recall: The wheel castor assemblies may be loosening on the stretchers.
FDA root cause: Mixed-up of materials/components
Action: Ferno initiated contact with customers via email and telephone on Wednesday, December 3, 2014. The firm will replace all wheel caster assemblies.
Quantity in commerce: 46 units
Distribution: The affected product was distributed to the following states: OH, MA, HI, NJ, TN, TX, MO, and GA. The affected product was distributed to the following foreign countries: Canada, Germany and Venezuela.
Product codes and lots: The following serial numbers are affected by this recall: 13N272700 13N273357 13N273915 13N274967 13N275720 13N272701 13N273358 13N273916 13N274968 13N275721 13N272702 13N273359 13N273917 13N274969 13N275722 13N272703 13N273360 13N274387 13N274970 13N275723 13N272704 13N273361 13N274388 13N274971 13N275724 13N272705 13N273362 13N274389 13N274972 13N275725 13N273353 13N273363 13N274390 13N274973 13N275726 13N273354 13N273902 13N274391 13N275717 13N273355 13N273913 13N274965 13N275718 13N273356 13N273914 13N274966 13N275719

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0995-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0995-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-16

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)