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U.S. Department of Health and Human Services

Class 2 Device Recall Wheel caster set screw for Ferno iNX Wheeled Stretcher

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 Class 2 Device Recall Wheel caster set screw for Ferno iNX Wheeled Stretchersee related information
Date Initiated by FirmMay 01, 2015
Date PostedAugust 25, 2015
Recall Status1 Terminated 3 on November 06, 2015
Recall NumberZ-2461-2015
Recall Event ID 71556
Product Classification Stretcher, wheeled - Product Code FPO
ProductWheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
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.
Recalling Firm/
Manufacturer		 Ferno-Washington Inc
70 Weil Way
Wilmington OH 45177-9371
For Additional Information ContactMrs. Dorothy A. Deaton
937-283-2885
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionFerno's first action of May 1, 2015 was to telephone all customers to alert them to the potential issue and explain our planned inspection. Ferno's Technical Support Manager emailed a copy of the Service Notice and iNX Equipment Evaluation Form to the customers as well.
Quantity in Commerce26 units
DistributionDistributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.
Total Product Life CycleTPLC 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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