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Aesculap, Inc. recalls Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid
Recalled February 4, 2015 · FDA recall Z-1012-2015 · Aesculap
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). · FDA Class II
Units
772
Sold at
Worldwide Distribution - US Nationwide
Description
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).
Product
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.
Manufacturer(s)
Aesculap, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →