Recall Z-2465-2008 ยท FPO Stretcher, Wheeled
Ferno-Washington Inc
Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance stretcher is used to transport a patient during rescue or emergency situations as well as a means to transport patients for general medical purposes.
| Date | Sep 30, 2008 (initiated Sep 3, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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 of Austria, China, Egypt, Germany, Hong Kong, Japan, Lebanon, Mexico, Poland, United Kingdom, and So |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.