Reported Mar 1, 2017 · Terminated
Hidrex USA DVP1000
Hidrex GmbH
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hidrex GmbH · Otto-Hahn-Str. 12 · Heiligenhaus, N/A · N/A
Is this the product you have?
- Hidrex USA DVP1000
- Lot codes and dates
SN# 16-3.6190 to 16-3.631917-3.6001 to 17-3.6050
- Amount recalled
- 180 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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