Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valv

FDA device recall Z-1810-2013 · posted 2013-07-25 · Terminated

Recall details

Recalling firm

Medtronic Neurosurgery

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.

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.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

KYZ

Quantity affected

915 units

Distribution

Nationwide Distribution in the US.

Date initiated

2013-06-28

Date posted

2013-07-25

Date terminated

2013-09-23

Location

Goleta, CA