MASSDEVICE ON CALL — Baxter (NYSE:BAX) said the U.S. Securities & Exchange Commission wants documents on the recalls of a pair of its infusion pumps, which the FDA forced from U.S. shelves in 2010.
The Chicago-based company said in a regulatory filing that the financial watchdog sent it a subpoena in March 2012 "related to the company’s accounting treatment, financial reporting and disclosures relating to the remediation and recall of the company’s Colleague and Syndeo infusion pumps," according to the filing. "The company is fully cooperating with this investigation."
In May 2010, the FDA made Baxter yank the Colleague line, accusing it of a "long-standing" failure to correct problems with the pumps, and ordered the company to provide refunds to customers or to replace the pumps at no cost.
Problems with infusion pumps in general prompted the FDA to look at stricter regulation of the devices, which are designed to deliver medications, including insulin for diabetes, at a controlled pace. The agency issued nearly 20 recalls over 5 years and said it received more than 56,000 complaints associated with the use of the pumps, scores of which resulted in serious injuries and 500 deaths.
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