FDAFDA · Food and drugs·Recall number Z-0814-2015
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Published December 24, 2014 · Recall initiated: November 11, 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
Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- Distributed in OK, and WI.
- Lot
- Catalog No: FV660T Lot No: 4506022655
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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