FDAFDA · Food and drugs·Recall number Z-0398-2014
Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into 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: D01859; D11969; D15985; D25462; D37523; D42401.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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