FDAFDA · Food and drugs·Recall number Z-0399-2014
Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
Published December 4, 2013 · Recall initiated: November 18, 2013
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
Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neurosurgery
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.
- Lot
- Lot Numbers: D22311; D37565.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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