Recall Z-0399-2014— Medtronic Neurosurgery
Class II · Terminated
Class II FDA medical device recall by Medtronic Neurosurgery, initiated 2013-11-18, terminated 2014-02-06. It names one FDA 510(k) clearance: K042465. Product: 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..
- Recalling firm
- Medtronic Neurosurgery
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-18
- Terminated
- 2014-02-06
- Firm location
- Goleta, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.