FDA Expands Class I Recall of Baxter Infusion Pumps
The US Food & Drug Administration and Baxter Healthcare Corporation (NYSE: BAX) have announced the Class I recall of 986 additional COLLEAGUE volumetric infusion pumps.
This notification expands on a previously announced recall of Baxter-manufactured COLLEAGUE and FLO-GARD infusion pumps which took effect on June 21, 2007.
The action was initiated after FDA officials became aware that repair reports and electrical safety data was falsified by three former employees at Baxter’s Phoenix, Arizona, service center.
Class I recalls are reserved for defective or dangerous products that could cause serious injury or death. Consumers who are in possession of the recalled pumps should return them immediately to Baxter. The company is prepared to loan pumps to people who require them while their items are being inspected and serviced.
Additional information on the recall can be obtained at www.baxter.com or by contacting the company’s toll free number at 1-800-843-7867. Representatives are available to answer your questions Monday through Friday from 7 am to 5 pm CDT.
Sources: FDA MedWatch and United Press International Science
Related Links: The New York Times; Reuters; PR Newswire
tags: occlusion
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