Medical Device Maker Expands Class I Recall

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August 8th, 2007

"Baxter Recalls 1,000 Additional Infusion Pumps"

Baxter Healthcare Corporation has expanded a Class I recall to include nearly 1,000 additional electronic infusion pumps because of falsified inspection reports and safety data.

Last month, the company announced a Class I recall of 534 of its COLLEAGUE and FLO-GARD infusion pumps—medical devices that deliver medications and other fluids to a patient in controlled amounts. The recall now includes an extra 986 Colleague infusion pumps.

Falsified Service Data

The company issued the recall after discovering falsified service data. According to the Food and Drug Administration, medical devices that were sent to Baxter's service center in Phoenix, Arizona, may have been returned to customers without being serviced or repaired.

Potential Risks

A Class I recall is the most urgent type of recall and indicates a potential risk of serious injury or death. Pumps that went without servicing or repair could lead to under- or over-infusion, electrical shock, failure to detect blockage, and other device malfunctions.

For some patients, an interruption in therapy could result in death. Individuals using one of the recalled pumps should return it to Baxter for servicing. The company said it would provide customers with loaner pumps at no charge.

(Source: FDA website)

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