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Terminated

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.

FDA Recall Z-1810-2013 · Posted 2013-07-25

Recall StatusTerminated
Product CodeKYZ
Date Initiated2013-06-28
Date Terminated2013-09-23
Product Quantity915 units

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.

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

Nationwide Distribution in the US.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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