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Infusion Pump Recalled After FDA Toughens Rules

This blog has run many posts about the dangers that defective medical devices present to the general public. On April 28 we reported that the Food and Drug Administration, or FDA, was issuing preliminary rules toughening the rules for approving the commercial sale of infusion pumps.

Now there is a new development: the main U.S. subsidiary of Baxter International has announced the recall of its Colleague infusion pump from the American market. The recall may involve up to 200,000 pumps already in use, and the model will be phased out, according to a company spokeswoman.

Spokeswoman Erin Gardner also said that Baxter will offer to replace recalled units of the Colleague pump with its Sigma Spectrum model.

In a related development, Hospira announced recently that it would stop shipments of its Symbiq pump following reports that the alarm on the device was not working properly.

Infusion pumps are intended to improve control and accuracy with drug delivery and to reduce medication errors. They are used for such serious cases as patients who are in comas or are receiving cancer treatment. There is no room for use of dangerous medical devices in such cases, and in medicine, defects mean danger.

If you are wondering about the dangers of other defective products to you or your family, there’s one thing you can do: get advice from people who know the subject. The pharmaceutical attorneys at Schlichter, Bogard & Denton are ready to work with you to determine if you have a possible case. We urge you to contact us for a confidential discussion at any of our nationwide offices.

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