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Class I recall shows importance of quality control

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 10, 2007

A device company's quality control processes helped it uncover "falsified repair, test, and inspection data sheets" that led to a recall of infusion pumps.

The pumps had been brought to Baxter Healthcare Corporation's service center for routine maintenance or corrections, but quality control processes revealed those pumps may not have been serviced, according to a July press release issued by Baxter. Baxter recalled the affected devices and dismissed three employees connected with the issue. The company also advised any affected customers to return the pumps for inspection. Only pumps distributed in the United States are affected, according to Baxter.

Just last month, Baxter extended the recall to include additional pumps that must be returned for inspection "because of falsified electrical safety data," according to an August 7 press release. Baxter revised the recall to include any pumps serviced by the three dismissed employees. No injuries or deaths have resulted from the problem and Baxter continues to investigate.

The FDA has classified the recall as a Class I recall and issued a Preliminary Public Health Notification in August, citing the risk of serious injury or death if an infusion pump malfunctions. The FDA notification advises customers to

• remove an affected pump from service
• return the pump to the company
• check to see if other models unaffected by this recall are safe to use and are not subject to earlier recalls.

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