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U.S. Department of Health and Human Services

Class 2 Device Recall Ferno Model 35X PROFlexX Ambulance Stretcher

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  Class 2 Device Recall Ferno Model 35X PROFlexX Ambulance Stretcher see related information
Date Initiated by Firm September 03, 2008
Date Posted September 30, 2008
Recall Status1 Terminated 3 on September 27, 2012
Recall Number Z-2465-2008
Recall Event ID 49500
Product Classification Stretcher - Product Code FPO
Product 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.
Code Information Serial Numbers Range between 06-002156 and 07-054091.
Recalling Firm/
Manufacturer		 Ferno-Washington Inc
70 Weil Way
Wilmington OH 45177
For Additional Information Contact Thomas E. Livingston
937-382-1451 Ext. 1285
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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 South Africa.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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