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FDAFDA · Food and drugs·Recall number Z-1676-2014

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.

Published June 11, 2014 · Recall initiated: April 21, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Aesculap, Inc.
Distributor
US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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