Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is int...
FDA Recall #Z-0989-2014 — Class II — December 23, 2013
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.
Recalling Firm
Aesculap, Inc. — Center Valley, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
4 lots: 4505268906, 4505336973, 4505408485, 4505238953
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated