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Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to sh...

FDA Recall #Z-1012-2015 — Class II — December 17, 2014

Recall #Z-1012-2015 Date: December 17, 2014 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

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).

Recalling Firm

Aesculap, Inc. — Center Valley, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

772

Distribution

Worldwide Distribution - US Nationwide

Code Information

material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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