Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance stre

FDA device recall Z-2465-2008 · posted 2008-09-30 · Terminated

Recall details

Recalling firm

Ferno-Washington Inc

Reason for recall

The Ferno Model 35-X PROFlexx legs could experience metal fatigue and possibly fracture after one to two years of use based on the usage and method of operation.

Action taken

On 9-03-2008 the firm sent via certified mail Urgent Voluntary Correction letters to their customers instructing them to immediately inspect the stretcher according to the 35X PROFlexx Leg Inspections instruction sheet. Customers are to also telephone the firm upon completion of the inspection to arrange for a replacement kit. Contact Ferno Technical Support at 1-866-987-3776 for assistance.

Root cause

Device Design

Status

Terminated

Product code

FPO

Quantity affected

2,100

Distribution

Worldwide Distribution --- USA including states of AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NM, NY,OH, OK, PA, SC, TN, TX, VA, WI, and WV, and countries

Date initiated

2008-09-03

Date posted

2008-09-30

Date terminated

2012-09-27

Location

Wilmington, OH