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 |
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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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