Company: Medica Corp.
Date of Enforcement Report: 9/5/01
Class: III

RECALL NUMBER, PRODUCT AND CODE:
Z-0951-1 EasyBlood Gas Analyzer.

REASON:
PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg.

CODES:
EasyBlood Gas Analyzers with Software version below M4.20.

MANUFACTURER/RECALLING FIRM:
Medica Corp., Bedford, MA.

RECALLED BY:
Manufacturer, by fax on 8/15/00.

FIRM INITIATED RECALL:
Ongoing.

DISTRIBUTION:
Malaysia, Russia, Hong Kong, Switzerland, Argentina, Czech Republic, Canada, Hungary, Chile Finland, Turkey, Italy, South Africa, Korea, Pakistan, Greece, Portugal, Mexico, Venezuela, Philippines, Bangladesh.

QUANTITY:
229.