Company: Medtronic MiniMed
Date of Enforcement Report: 1/21/04
Class: III
PRODUCT
Medtronic MiniMed. Model 7311 Solutions Pumps
and Meters Software. Recall # Z-0265-04.
REASON
Accessory software fails to report certain reports following download of data from 712 pump.
CODE
Version 5.0A.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by visit or FedEx software on CD-rom beginning on November 19, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,020.
DISTRIBUTION
Nationwide and Internationally.