Baxter International Gets FDA Orders to ‘Recall and Destroy’ Defective Infusion Pumps
Baxter International Gets FDA Orders to ‘Recall and Destroy’ Defective Infusion

The Food and Drug Administration has asked Baxter International Inc. to recall 200,000 of the company's Colleague brand pumps, accelerating its examination of infusion pumps used mostly in hospitals to give fluids to patients.

The FDA said that the Deerfield, Ill.-based drug and device maker must "recall and destroy" all of its Colleague pumps, saying that the movement was based on "a long-standing failure" of the organization to rectify critical problems with them.

Baxter will earn a special pretax fee of $400 million to $600 million in its first quarter to make up for the expenditure of the recall.

Bob Parkinson, Baxter's Chairman and Chief Executive, speaking to shareholders on Tuesday, attending the company's annual conference in Deerfield, said, "The situation has languished far beyond what it should have".

Infusion pumps are machines generally seen in hospitals, delivering liquid, medicine and nutritional fluids by means of a timing mechanism, which regulates the amount of medication that a patient gets.

The FDA said that infusion pumps, together with Baxter's Colleague, had resulted in "persistent safety problems".

In the last five years, the FDA has received over 56,000 reports of adverse happenings, which included critical damages and over 500 deaths.

However, the agency did not reveal that how many unpleasant incidents were related to Baxter's Colleague pump.

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