Date Initiated by Firm | January 30, 2017 |
Date Posted | February 22, 2017 |
Recall Status1 |
Terminated 3 on August 04, 2017 |
Recall Number | Z-1237-2017 |
Recall Event ID |
76362 |
510(K)Number | K133033 |
Product Classification |
Device, iontophoresis, other uses - Product Code EGJ
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Product | Hidrex USA DVP1000 |
Code Information |
SN# 16-3.6190 to 16-3.6319, 17-3.6001 to 17-3.6050 |
Recalling Firm/ Manufacturer |
Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany
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Manufacturer Reason for Recall | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
FDA Determined Cause 2 | Error in labeling |
Action | Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed to be returned. |
Quantity in Commerce | 180 units |
Distribution | Nationwide throughout the US |
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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510(K) Database | 510(K)s with Product Code = EGJ
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