Recall Z-1859-2008 ยท FPO Stretcher, Wheeled
Ferno-Washington Inc
Model 35A Series Mobile Transporters is an ambulance stretcher for patient transport.
| Date | Sep 11, 2008 (initiated Apr 29, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 cu |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.