FDAClass IIJune 11, 2014

Aesculap Inc.(AIC) Miethke Ventricular Catheter with recall

Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid…

Why was Aesculap Inc.(AIC) Miethke Ventricular Catheter with recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid…
Recalling firm
Aesculap, Inc.
Quantity
48
Distribution
US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
Recall date
June 11, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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