FDA Enforcement
Class II
Terminated
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.
Recall: Z-0399-2014
·
Reported December 4, 2013
Enforcement
- Recall Number
- Z-0399-2014
- Event ID
- 66882
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Neurosurgery
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2013
- Initiation Date
- November 18, 2013
- Classification Date
- November 26, 2013
- Termination Date
- February 6, 2014
- Address
- 125 Cremona Dr, N/A, Goleta, CA, 93117-3083, United States
Description
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.
Reason
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.
Code Info
Lot Numbers: D22311; D37565.
Distribution
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.
Quantity
5 units