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Class 2 Device Recall Wheel caster set screw for Ferno iNX Wheeled Stretcher |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
May 01, 2015 |
Date Posted |
August 25, 2015 |
Recall Status1 |
Terminated 3 on November 06, 2015 |
Recall Number |
Z-2461-2015 |
Recall Event ID |
71556 |
Product Classification |
Stretcher, wheeled - Product Code FPO
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Product |
Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
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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
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For Additional Information Contact |
Mrs. Dorothy A. Deaton 937-283-2885
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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.
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FDA Determined Cause 2 |
Process control |
Action |
Ferno'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 Commerce |
26 units |
Distribution |
Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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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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