FDA-Device2013-07-31Class II
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.
Medtronic Neurosurgery
Hazard
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.
Sold states
Nationwide Distribution in the US.
Affected count
915 units
Manufactured in
125 Cremona Dr, N/A, Goleta, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1810-2013Don't want to check this manually?
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