Recall Z-1810-2013— Medtronic Neurosurgery
Class II · Terminated
Class II FDA medical device recall by Medtronic Neurosurgery, initiated 2013-06-28, terminated 2013-09-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.. Reason: Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit..
- Recalling firm
- Medtronic Neurosurgery
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-28
- Terminated
- 2013-09-23
- Firm location
- Goleta, CA, United States
Product description
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
Reason for recall
Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.