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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Baxter Provides Update on Service Documentation Class I Recall

 

Models Include: COLLEAGUE Mono Volumetric Infusion pump, Product Codes 2M8151 and 2M8153; COLLEAGUE CX Volumetric Infusion pump, Product Codes 2M8161 and 2M8163; FLO-GARD 6201 Volumetric Infusion pump, Product Code 2M8063; and FLO-GARD 6301 Volumetric Infusion pump, Product Code 2M8064 

 

Contact:
Baxter Healthcare Corporation
1-800-843-7867

 

FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., August 7, 2007 – Baxter Healthcare Corporation today announced an update to the July 25, 2007 Class I recall press release regarding falsified repair, test and inspection data sheets, which included electrical safety data for COLLEAGUE and FLO-GARD infusion pumps. Baxter has expanded the recall to include an additional 986 COLLEAGUE infusion pumps, which need to be returned to the company for repeat inspection, because of falsified electrical safety data.

As announced on July 25, 2007, in the course of its ongoing quality control processes, the company discovered falsified service documentation data. Therefore, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. Previously, the recall pertained to 534 infusion pump devices serviced in the company's Phoenix, Arizona service center. The expansion of the recall represents pumps serviced by all three employees previously mentioned who have been dismissed. Baxter's investigation of the matter is continuing. The company will continue to provide updates and instructions to users regarding the service documentation recall on www.baxter.com.

The company has informed all customers to contact Baxter and return affected pumps for repeat inspection and servicing and will provide loaner pumps free of charge. There are no serious injuries or patient deaths associated with this action to date. This recall action impacts only pumps distributed in the United States.

This issue was classified by FDA as a Class I recall on July 24, 2007, 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 Model Numbers 6201 and 6301 Volumetric Infusion pump, Product Codes: 2M8063 and 2M8064; COLLEAGUE Volumetric Infusion pump, Product Codes: 2M8151 and 2M8153; and COLLEAGUE CX Volumetric Infusion pump, Product Codes: 2M8161 and 2M8163. The Agency is expected to issue a Preliminary Public Health Notification on Baxter's service documentation recall.

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 servicing and inspection or for loaner devices, free of charge. Representatives are available Monday through Friday from 7 a.m. to 5 p.m. CDT.

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