Healthcare Industry News:  kidney disease 

Devices Product Recall FDA

 News Release - July 25, 2007

FDA Classifies Baxter's Voluntary Recall Action Regarding Service Documentation as a Class I Recall

Models Include: COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; COLLEAGUE CX Volumetric Infusion pump 2M8161 and 2M8163; and FLO-GARD Volumetric Infusion pump 2M8063 and 2M8064

DEERFIELD, Ill., July 25 (HSMN NewsFeed) -- Baxter Healthcare Corporation today announced that the U.S. Food and Drug Administration (FDA) has classified Baxter's voluntary recall action regarding falsification of service and repair data for the COLLEAGUE and FLO-GARD infusion pumps as a Class I recall. The recall pertained to 534 infusion pump devices in the U.S. brought in for routine maintenance or corrections at the company's Phoenix, Arizona service center. In the course of its ongoing quality control processes, the company discovered falsified repair, test and inspection data sheets, which included electrical safety data. Therefore, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. Three employees in the Phoenix service center associated with this matter have been dismissed. The company has recalled affected devices and has informed all customers to contact Baxter and return the pumps for repeat inspection. All affected customers have been notified and no serious injuries or patient deaths have been associated with this action to date. This recall action impacts only pumps distributed in the United States.

This action has been classified by FDA as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. A defect may result in over-infusion, under-infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line, and malfunctions where the pump will stop infusing and result in an interruption of therapy. Affected model numbers include: FLO- GARD Volumetric Infusion pump 2M8063 and 2M8064; COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; and COLLEAGUE CX Volumetric Infusion pump 2M8161 and 2M8163.

Customers with questions regarding this notice or who have affected pumps should contact Baxter at 1-800-843-7867 (1-800-THE-PUMP) and arrange for a repeat inspection and servicing or for loaner devices, free of charge. Representatives are available Monday through Friday from 7 a.m. to 5 p.m. CDT.

Baxter International Inc. (NYSE: BAX ), through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. For more information about Baxter, visit http://www.baxter.com.


Source: Baxter

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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