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U.S. Department of Health and Human Services

Class 3 Device Recall Hidrex USA DP450

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 Class 3 Device Recall Hidrex USA DP450see related information
Date Initiated by FirmJanuary 30, 2017
Date PostedFebruary 22, 2017
Recall Status1 Terminated 3 on August 04, 2017
Recall NumberZ-1236-2017
Recall Event ID 76362
510(K)NumberK133033 
Product Classification Device, iontophoresis, other uses - Product Code EGJ
ProductHidrex USA DP450
Code Information SN# 16-3.7091 to 16-3.7134, 17-3.7001 to 17-3.7020
FEI Number 3008642982
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
ActionDistributor 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 Commerce64 units
DistributionNationwide throughout the US
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = EGJ
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