Company: Abbott Laboratories, Inc
Date of Enforcement Report: 5/28/03
Class: II
PRODUCT
a) Gemstar_ 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9
Software Version. Recall # Z-0792-03;
b) Gemstar_ 6 Therapy I.V. Infusion Pump, List#: 13100-04; 2.9
Software Version. Recall # Z-0793-03;
c) Gemstar_ Therapy Pain Management I.V. Infusion Pump,
List#: 13150-04; 2.9 Software Version. Recall # Z-0794-03;
REASON
Products contain software deficiencies which could allow over infusion thereby administering excess medication.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Morgan Hill, CA, by letters on April 1, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,310 units.
DISTRIBUTION
Nationwide.
