Class 1 Recall: Baxter Healthcare Corp. COLLEAGUE® and FLO-GARD® Volumetric Infusion Pumps

June 21, 2007

Baxter Colleague ® and FLO-GARD ® Volumetric Infusion Pumps

• COLLEAGUE ® Mono Single Channel Volumetric Infusion Pump; Product Code 2M8151

• COLLEAGUE ® CX Single Channel Volumetric Infusion Pump; Product Code 2M8161
   
  See: Recall for Colleague and Colleague CX Infusion Pumps for the list of serial numbers http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=53189

• COLLEAGUE ® Mono Triple Channel Volumetric Infusion Pump; Product Code 2M8153

• COLLEAGUE ® CX Triple Channel Volumetric Infusion Pump; Product Code 2M8163
   
  See: Recall for Colleague and Colleague 3 CX Triple Channel Infusion Pumps for the list of serial numbers http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=53190
   
  See also: June 20, 2007, Recall for Baxter Upgraded COLLEAGUE ® Triple Channel Volumetric Infusion Pumps http://www.fda.gov/cdrh/recalls/recall-062007.html

• FLO-GARD ® 6201, Single Channel Volumetric Infusion Pump; Product Code 2M8063
   
  See: Recall for Baxter FLO-GARD 6201 Volumetric Infusion Pumps for the list of serial numbers http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=53174

• FLO-GARD ® 6301, Dual Channel Volumetric Infusion Pump; Product Code 2M8064
   
  See: Recall for Baxter FLO-GARD 6301 Dual Channel Volumetric Infusion Pumps for the list of serial numbers http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=53176

From April, 2006 through February, 2007, Baxter distributed 534 pumps to 180 customers (including distributors, medical facilities, retail companies and one institution) within the U.S. On August 3, 2007, Baxter expanded the electrical data recall to include an additional 986 Colleague Pumps to 178 customers within the US.

Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.

The firm identified repair, inspection & test data sheets, which included electrical safety data, for the pumps, that were falsified.

On June 21, 2007, Baxter contacted their customers informing them that the company discovered, during ongoing quality control processes, that repair, test and inspection data sheets, including electrical safety data, were falsified. As a result, it may be possible that pumps sent to be serviced, repaired, or corrected were returned without service being performed on them. This 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 that can result in death.

The company requested their customers to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for repeat inspections and servicing. Baxter will provide loaner pumps to customers that require them, free of charge.

Customers with questions regarding affected pumps should contact Baxter at 1-800-843-7867. Baxter will accept calls from Monday through Friday, 7 a.m. to 5 p.m.

For more information about this recall, please see the company’s press release at:

http://www.baxter.com/about_baxter/news_room/news_releases/2007/08-07-07-service_documentation_update.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178