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U.S. Department of Health and Human Services

Class 2 Device Recall Wheeled Ambulance Stretchers

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  Class 2 Device Recall Wheeled Ambulance Stretchers see related information
Date Initiated by Firm April 29, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on October 30, 2012
Recall Number Z-1859-2008
Recall Event ID 48146
Product Classification Wheeled Stretcher - Product Code FPO
Product Model 35A Series Mobile Transporters is an ambulance stretcher for patient transport.
Code Information The following Models within the 35A series were subject to recall: (35-A, 35-AST, 35-A+, 35ITA, 35-ITDS, 35-ANM, 35-A+ST, 35-SL, 35-ITIB, 35-L). The following Serial Numbers  were subject to recall:    SERIAL  07047767  07047768  07047769  07047770  07047771  07048489  07049108  07049109  07049111  07049112  07049113  07049114  07049115  07049116  07049118  07049119  07049120  07049122  07049123  07049124  07049166  07049167  07049168  07049169  07049170  07049171  07049172  07049173  07049174  07049175  07049176  07049177  07049178  07049179  07049180  07049181  07049182  07049183  07049723  07049724  07049726  07049727  07049728   07049729  07049730  07049731  07049732  07049733  07049734  07049735  07049736  07049737  07049775  07049776  07049777  07049778  07049779  07049780  07049781  07049782  07049783  07049784  07050473  07050474  07050475  07050476  07050477  07050478  07050479  07050480  07050481  07050482  07050483  07050484  07050485  07050486  07050487  07050488  07050489  07050490  07050491  07050492  07050493  07050494  07050495  07050496  07050497  07050564  07050565  07050566  07051124  07051144  07051145 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 BBB113844  BBB113845  BBB113846  BBB113847  BBB113848  BBB113849  BBB113850  BBB113851  BBB113852  BBB113853  BBB113854  BB8113855, and  8BB113856     
Recalling Firm/
Manufacturer		 Ferno-Washington Inc
70 Weil Way
Wilmington OH 45177-9371
For Additional Information Contact
937-382-1451 Ext. 1285
Manufacturer Reason
for Recall		 A component defect was found in corner castings of the firm's wheeled ambulance stretchers. Some corner castings on the stretchers were found to be over-sized. Using an over-sized cone-shaped hole corner casting with an improperly seated shank pin could put undue stress on the top screw, possibly causing the screw securing a wheel to become loose or break and the wheel to detach from the stretcher
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm sent an 'Urgent Field Correction' notification letter to their customers, via certified mail on 5/16/2008. The letter instructs the customers to examine all inventory of Model 35A stretchers. The letter also recommends that any identified unit be removed from service until the unit has been inspected by the customer and a field correction completed, if applicable. Once the inspection of the unit(s) has been completed by the customer, they are to contact the firm immediately and inform them of the results of t their inspections. In the event that a casting fails inspection, the customer is instructed to contact Ferno's Technical Support Div. in order to arrange for a casting replacement. To report the results of their inspection(s) or to address any questions or concerns which the customer may have, contact Ferno Technical Support at 1-866-987-3776 or send an email to Quality.Products@ferno.com.
Quantity in Commerce 783 units
Distribution The recalled product was distributed to customers in the following location nationwide: 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.
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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