Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Reported: February 26, 2014 Initiated: December 23, 2013 #Z-0989-2014
Product Description
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Reason for Recall
The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Details
- Recalling Firm
- Aesculap, Inc.
- Units Affected
- 79
- Distribution
- Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.. Recalled by Aesculap, Inc.. Units affected: 79.
Why was this product recalled? ▼
The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-0989-2014.
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