FDA Gives Baxter a Two-Year Window to Pull Pumps Off Market

The U.S. Food and Drug Administration (FDA) has given Baxter International Inc. two years to recall about 200,000 Colleague-brand drug-infusion pumps in the United States in addition to offering customers either refunds or replacement devices.

The recall was announced in May. The agency said the company’s initial plan to start correcting pumps in May 2012 and finish the following year, was “unacceptable,” but it gave the company 24 months to accommodate hospitals. Industry analysts hadn’t expected such a big window of time. This could help Baxter and hurt competitors—Hospira and CareFusion—hoping to take advantage of the situation.

Infusion pumps deliver intravenous fluid and drugs in a controlled fashion. Baxter’s Colleague line of pumps has devices has been a problem for a number of years and has been linked to reports of patient injuries and deaths.

The Deerfield, Ill., company had been fixing pumps in the field for years, but the FDA decided that it didn’t like Baxter’s latest remediation timeline, and it ordered the company to pull pumps off the market while offering refunds or replacements at no charge.

Baxter is offering Spectrum-brand pumps from a private company called Sigma International, where Baxter has a 40 percentownership stake. Baxter’s ability to get enough Spectrum pumps to fill customer demand has been in doubt.

FDA officials also said that Baxter would not be required to offer a competitors’ pump. The FDA set the refund amounts for Colleague pumps, based on their depreciated value, between $1,500 and $3,000 depending on the type of pump. Customers will not be refunded more than they paid, however.

Baxter said customers who didn’t buy their pumps directly from the company must provide proof of purchase to qualify for a refund. Baxter also plans to allow those leasing pumps to terminate their leases without penalty following a return of the devices.