Company: Medtronic Inc
Date of Enforcement Report: 9/29/04
Class: I
PRODUCT
8870 software application card Version AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N’Vision Clinician Program. Recall # Z-1334-04.
REASON
Users may mistakenly enter a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.
CODE
Software Version AAA 02, BBB 04, BBC 02, and BBD 01.
RECALLING FIRM/MANUFACTURER
Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN, by letters on August 24, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4,466 cards.
DISTRIBUTION
Nationwide and Internationally.
