Z-2461-2015 Class II Terminated
FDA device recall Z-2461-2015 was initiated by Ferno-Washington Inc on May 1, 2015 and is designated Class II. Reason for recall: The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the… The recall status is terminated (terminated November 6, 2015). Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- May 1, 2015
- Termination Date
- November 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
Reason for Recall
The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use.
Distribution Pattern
Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.
Code Information
Serial numbers: 15F001703, 15F001704, 15F001705, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001714, 15F001715, 15F001716, 15F001717, 15F001719, 15F001720, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001729 & 15F001730.