Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2826-2015Class II

Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System

Ferno-Washington Inc / initiated 2015-08-03 / Terminated / root cause: design

Ferno-Washington Inc began a recall of Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital patient transport on . FDA classified it as Class II and gives the reason as "Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2826-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ferno-Washington Inc
Product
Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital patient transport.
Product code
FPO Stretcher, Wheeled
Reason for recall
Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame.
Root cause tag
design
FDA root cause
Device Design
Action
Ferno began calling their customers on 8/3/2015. The firm informed their customers of the following: To provide optimal Customer Experience and minimal disruption to your service, the iNX field action involves the following steps: " Exchange of your current iNX with a new iNX; " Participation in a brief training session; and " Inspection of your Ferno Model 175 antler and rail fastening system as requested by the Dept. of Transportation. As you await delivery of your new iNX, it is important you ensure proper function of the fastening system and iNX telescoping load frame.
Quantity in commerce
72 units
Distribution
Worldwide Distribution - US Nationwide in the states of: CO, IA, IL, IN, KY, MD, MN, MO, NC, NJ, NY, OH, OK, OR, TX, VA, WA & WY and the countries of CANADA, AUSTRALIA, UNITED KINGDOM & NEW ZEALAND.
Product codes and lots
Serial #s: 15F001703, 15F001704, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001715, 15F001717, 15F001719, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001728, 15F001729, 15F001730, 15F001731, 15F001732, 15F001733, 15F001734, 15F001735, 15F001736, 15F001737, 15F001738, 15F001739, 15F001740, 15F001741, 15F001742, 15F001744, 15F001745, 15F001746, 15F001747, 15F001748, 15F001749, 15F001750, 15F001751, 15F001752, 15F001753, 15F001754, 15F001755, 15F001756, 15F001757, 15F001758, 15F001759, 15F001760, 15F001761, 15F001762, 15F001763, 15F001764, 15F001765, 15F001766, 15F001767, 15F001768, 15F001769 5F001770, 15F001771, 15F001772, 15F001773, 15F001774, 15F001775, 15F001776, 15F001777, 15F001778, 15F001779, 15F001780, 15F001781, 15F001782, 15F001783, 15F001784, 15F001785, 15F001786, 15F001787, 15F001788, 15F001789, 15F001790, 15F001791, 15F001793, 15F001794, 15F001795, 15F001796, 15F001797, 15F001798, 15F001804, 15F001805, 15F001806, 15F001807, 15F001808, 15F001809, 15F001810, 15F001811, 15F001812, 15F001813, 15F001814, 15F001815, 15F001816 & 15F001850.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2826-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2826-2015Class IITerminatedVoluntary: Firm initiated