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September 13, 2000

Attention Health Professional: Medical Device Safety Alert

Lakewood, CO (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that GAMBRO BCT, Inc., is recalling its COBE BCT brand Trima Automated Blood Component Collection System because failure to follow instructions could cause air embolism.

COBE BCT brand Trima Automated Blood Component Collection System, a transportable automated system that separates whole blood from a donor into its major components.

Safety Alert #N-017-0.

Catalog #91700-000, All serial numbers.

GAMBRO BCT, Inc., Lakewood, Colorado.

Manufacturer, by letter on August 4, 2000, and by letter. Firm-initiated recall ongoing.

Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chili, Dominican Republic, Egypt,
France, Germany, Ireland, Israel, Italy, Japan, Korea, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Scotland, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom and Uruguay.

450 units.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.