The SEC wants to see Baxter International's ($BAX) financial records on the recalls of its Colleague and Syndeo infusion pumps back in 2010, which were pulled from shelves by the FDA.
Baxter disclosed that the commission issued a subpoena in March for "documents and other records related to the company's accounting treatment, financial reporting and disclosures" of the recalled pumps, MassDevice reports. Baxter divulged the information in two lines of the "Other" section of its latest 10-Q filing, adding that it is fully cooperating with the investigation and leaving it at that.
The 2010 recall followed what the FDA called Baxter's "longstanding failure" to fix problems with infusion pumps, and the company was required to provide refunds or replacement pumps to affected patients. At the time, Baxter estimated that the recall would cost it between $400 million and $600 million. But the company has rallied since then: During the recall, its shares dropped to around $40 but have since risen to close yesterday at $54.78.
That recall was part of a wave of problems with infusion pumps, the FDA noted. After many injuries and nearly 500 deaths led to 87 pump recalls between 2005 and 2009, the agency has since tightened its regulations on the devices.
- read MassDevice's report
- check out the SEC filing