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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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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
Distribution Pattern US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter. 48 Z-1676-2014