Ferno Model 35X PROFlexx Stretchers, one unit per package

FDA Recall #Z-0995-2015 — Class II — December 3, 2014

Recall #Z-0995-2015 Date: December 3, 2014 Classification: Class II Status: Terminated

Product Description

Ferno Model 35X PROFlexx Stretchers, one unit per package

Reason for Recall

The wheel castor assemblies may be loosening on the stretchers.

Recalling Firm

Ferno-Washington Inc — Wilmington, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated