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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Recall Number Z-1676-2014
Classification Class II
Code Info Catalog No: FV431T, FV434T, FV433T, FV459T, FV078P, FV494T, FV676T, FV324T Lot No: 4505150452,4505156642,4505164365,4505134636,4505150384,4505156634,4505246780,4505394315,4505150371,4505174213,4505187583,4505366616,4505134635,4505187582,4505134629,4505212089,4505199667,4505150340,4505171900,4505168804
Product Distributed Qty 48
Reason For Recall AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.

Event Detail

Event Id 68091
Product Type Devices
Status Ongoing
Recalling Firm Aesculap, Inc.
City Center Valley
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.