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U.S. Department of Health and Human Services

Class 3 Device Recall Hidrex USA DVP1000

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  Class 3 Device Recall Hidrex USA DVP1000 see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = EGJ and Original Applicant = HIDREX GMBH
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