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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65600
Product Type Devices
Status Ongoing
Recalling Firm Medtronic Neurosurgery
City Goleta
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-28
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution in the US.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. C22929 C40543 C56465 C80034 D16291 C25329 C42910 C57924 C80787 D16693 C25475 C43115 C62128 D00052 D20967 C25662 C43512 C65929 D01033 D22544 C28396 C45615 C66120 D07250 D25802 C29229 C46351 C68906 D07373 D30597 C33946 C46583 C69701 D07507 C36893 C49439 C71003 D10462 C36904 C49706 C73622 D11409 C38718 C51418 C76639 D13208 C39484 C52417 C78186 D14099 C40150 C53058 C79051 D16157 Class II 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. 915 units Z-1810-2013
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