Aesculap, Inc. recalls Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from…

Recall date

December 17, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1012-2015

FDA classification

Class II

Brand / firm

Aesculap, Inc.

Sold / distributed

Worldwide Distribution - US 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.