Recall Z-1810-2013
Medtronic Neurosurgery · initiated June 28, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-1810-2013
- Initiated
- June 28, 2013
- Posted by FDA
- July 25, 2013
- Terminated
- September 23, 2013
- Product code
- KYZ – Syringe, Irrigating (Non Dental)
- Quantity
- 915 units
- Distribution
- Nationwide Distribution in the US.
- Recalling firm
- Medtronic Neurosurgery, Goleta, CA