Reported Feb 4, 2015 · Terminated
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from…
Aesculap, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Aesculap, Inc. · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- 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
- Lot codes and dates
- material numbers
FV400TFV401TFV402TFV403TFV404TFV405TFV406TFV407TFV408TFV409TFV499TFV790TFV791TFV792TFV793TFV794TFV795TFV796T
- material numbers
- Amount recalled
- 772
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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