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

Source | FDA

Date Recall:  Initiated June 21, 2007
 
Product: Baxter Colleague® and FLO-GARD® Volumetric Infusion Pumps

• COLLEAGUE® Volumetric Infusion Pump (2M8151, 2M8153)
• COLLEAGUE® CX Volumetric Infusion Pump (2M8161, 2M8163)
• FLO-GARD® Volumetric Infusion Pump (2M8063, 2M8064)

From April, 2006 through February, 2007, Baxter distributed 534 pumps to 170 customers (including distributors, medical facilities, retail companies and one institution) within the U.S.

Use: 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.
 
Recalling Firm: Baxter Healthcare Corp., Rt. 120 & Wilson Rd., Round Lake, Illinois 60073 

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

FDA Comments: 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.

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

http://www.baxter.com/about_baxter/news_room/news_releases/2007/07-25-07-service_documentation.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.

See also: June 20, 2007, Recall for Baxter Upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps
http://www.fda.gov/cdrh/recalls/recall-062007.html