September 13, 2000Attention Health Professional:
Medical Device Safety Alert
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
France, Germany, Ireland, Israel, Italy, Japan, Korea, Netherlands, Norway, Poland,
Portugal, Saudi Arabia, Scotland, South Africa, Spain, Sweden, Switzerland, Turkey, United
Kingdom and Uruguay.
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notification visit: www.safetyalerts.com.