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.
Reported: February 4, 2015 Initiated: December 17, 2014 #Z-1012-2015
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).
Details
- Recalling Firm
- Aesculap, Inc.
- Units Affected
- 772
- Distribution
- Worldwide Distribution - US Nationwide
- Location
- Center Valley, PA
Frequently Asked Questions
What product 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.. Recalled by Aesculap, Inc.. Units affected: 772.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2015. Severity: Moderate. Recall number: Z-1012-2015.
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