Recall Z-1810-2013 ยท KYZ Syringe, Irrigating (Non Dental)
Medtronic Neurosurgery
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.
| Date | Jul 25, 2013 (initiated Jun 28, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 915 units |
| Distribution | Nationwide Distribution in the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.