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U.S. Department of Health and Human Services

Class 2 Device Recall Ferno Model 35X PROFlexx Stretchers

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  Class 2 Device Recall Ferno Model 35X PROFlexx Stretchers see related information
Date Initiated by Firm December 03, 2014
Date Posted January 16, 2015
Recall Status1 Terminated 3 on December 01, 2015
Recall Number Z-0995-2015
Recall Event ID 69978
Product Classification Stretcher, wheeled - Product Code FPO
Product Ferno Model 35X PROFlexx Stretchers, one unit per package
Code Information The following serial numbers are affected by this recall: 13N272700 13N273357 13N273915 13N274967 13N275720 13N272701 13N273358 13N273916 13N274968 13N275721 13N272702 13N273359 13N273917 13N274969 13N275722 13N272703 13N273360 13N274387 13N274970 13N275723 13N272704 13N273361 13N274388 13N274971 13N275724 13N272705 13N273362 13N274389 13N274972 13N275725 13N273353 13N273363 13N274390 13N274973 13N275726 13N273354 13N273902 13N274391 13N275717 13N273355 13N273913 13N274965 13N275718 13N273356 13N273914 13N274966 13N275719
Recalling Firm/
Manufacturer		 Ferno-Washington Inc
70 Weil Way
Wilmington OH 45177
For Additional Information Contact Jennifer L. Ingram
800-733-3766 Ext. 1450
Manufacturer Reason
for Recall		 The wheel castor assemblies may be loosening on the stretchers.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Ferno initiated contact with customers via email and telephone on Wednesday, December 3, 2014. The firm will replace all wheel caster assemblies.
Quantity in Commerce 46 units
Distribution The affected product was distributed to the following states: OH, MA, HI, NJ, TN, TX, MO, and GA. The affected product was distributed to the following foreign countries: Canada, Germany and Venezuela.
Total Product Life Cycle TPLC 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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