Reported Feb 26, 2014 · Terminated

Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut…

Aesculap, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aesculap, Inc. · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217

Is this the product you have?

  • 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.
Lot codes and dates
  • 4
  • lots
    • 4505268906
    • 4505336973
    • 4505408485
    • 4505238953
Amount recalled
79

Where it was sold

Why it was recalled

The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 1, 2014 · Data as of Sep 19, 6:49 PM UTC

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