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U.S. Department of Health and Human Services

Medical Devices

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Baxter Healthcare Corp. COLLEAGUE® and FLO-GARD® Volumetric Infusion Pumps (Updated August 8, 2007)

Class 1 Recall
Date Recall
Initiated:
June 21, 2007
Product:

Baxter Colleague ® and FLO-GARD ® Volumetric Infusion Pumps

  • COLLEAGUE ® Mono Single Channel Volumetric Infusion Pump; Product Code 2M8151. See the nearby link for serial numbers of pumps affected by this recall.
  • COLLEAGUE ® CX Single Channel Volumetric Infusion Pump; Product Code 2M8161. See the nearby link for serial numbers of pumps affected by this recall.
  • COLLEAGUE ® Mono Triple Channel Volumetric Infusion Pump; Product Code 2M8153. See the nearby link for serial numbers of pumps affected by this recall.
  • COLLEAGUE ® CX Triple Channel Volumetric Infusion Pump; Product Code 2M8163. See the nearby link for serial numbers of pumps affected by this recall.
  • FLO-GARD ® 6201, Single Channel Volumetric Infusion Pump; Product Code 2M8063. See the nearby link for serial numbers of pumps affected by this recall.
  • FLO-GARD ® 6301, Dual Channel Volumetric Infusion Pump; Product Code 2M8064. See the nearby link for serial numbers of pumps affected by this recall.

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.

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.
Public Contact:
Customers may call Baxter Healthcare Corp. at 1-800-422-9837
FDA District:
Chicago
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.

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.

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. See nearby link to MedWatch.