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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Preimplantation Test Kit,

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 Class 2 Recall
Medtronic Preimplantation Test Kit,
see related information
Date Posted July 25, 2013
Recall Status1 Terminated on September 23, 2013
Recall Number Z-1810-2013
Recall Event ID 65600
Product Classification Syringe, Irrigating (Non Dental) - Product Code KYZ
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.
Code Information 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
Recalling Firm/
Manufacturer
Medtronic Neurosurgery
125 Cremona Dr
Goleta, California 93117-3083
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
EXPIRATION DATING: Incorrect or No Expiration Date
Action An "Urgent Field Safety Notice" recall letter dated 6/28/13 was sent to customers who purchased the Medtronic Preimplantation Test Kit, catalog number 21047, to inform them of the recall due to the incorrect outer carton expiration dates. The recall letter informed the customers of the problems and actions identified. Customers were instructed to contact the Quality Department at (805) 571-8725 for questions.
Quantity in Commerce 915 units
Distribution Nationwide Distribution in the US.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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