FDAFDA · Food and drugs·Recall number Z-1012-2015
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Published February 4, 2015 · Recall initiated: December 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- Worldwide Distribution - US Nationwide
- Lot
- material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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