Reported Jul 31, 2013 · Terminated
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control…
Medtronic Neurosurgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neurosurgery · 125 Cremona Dr · Goleta, CA · 93117-3083
Is this the product you have?
- 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.
- Lot codes and dates
C22929C40543C56465C80034D16291C25329C42910C57924C80787D16693C25475C43115C62128D00052D20967C25662C43512C65929D01033D22544C28396C45615C66120D07250D25802C29229C46351C68906D07373D30597C33946C46583C69701D07507C36893C49439C71003D10462C36904C49706C73622D11409C38718C51418C76639D13208C39484C52417C78186D14099C40150C53058C79051D16157
- Amount recalled
- 915 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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