Class 1 Recall: Baxter Upgraded Colleague CX Single Channel Volumetric Infusion Pumps

August 15, 2007

Baxter Upgraded Colleague CX Single Channel Volumetric Infusion Pumps, model number 2M8161.

Serial numbers include: 14051565CC, 15034273CC, 15034492CC, 15040255CC, 15041116CC, 15041169CC, 15041170CC, 15041172CC, 15041181CC, 15041194CC, 15041199CC, 15041206CC, 15041212CC, 15041218CC, 15041241CC, 15041288CC, 15041290CC, 15041317CC, 15050020CC, 15050034CC, 15050045CC, 15050061CC, 15050080CC, 15050117CC, 15050129CC, 15060087CC, 15060217CC, 15060253CC, 15060479CC, 15060489CC, 15060549CC, 15060557CC, 15060600CC, 15060738CC, 15060790CC, 15060827CC, 15060939CC, 15060940CC, 15060968CC, 15063211CC, 15075103CC, 15075371CC

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.

A field service technician did not perform all of the hardware Recall: upgrades required in accordance with Baxter’s corrective action procedures related to eight open Colleague recalls. The service technician certified in the service documentation that the upgrades were done on the affected pumps even though the upgrades were not done. These incomplete upgrades were performed from May 22, 2007, through August 7, 2007.

On August 15, 2007, Baxter notified their customers that some of the Colleague pumps may not have been upgraded. The primary users of this device are hospitals. The company requested their customers to locate the affected pumps, take them out of service and notify Baxter to schedule a reinspection and servicing of the pumps.

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