The FDA has asked Baxter to provide additional information into modifications proposed for the medical device, forcing Baxter to suspend shipments since April of this year.
"Baxter anticipates resuming manufacturing of the SIGMA Spectrum infusion pump in Medina based on the clearance of our 510(k) submission with the FDA," Baxter spokesman John O’Malley told the Buffalo Business Journal, adding that the Medina facility is, "essential to Baxter’s ability to continue servicing and supporting customers who rely on the SIGMA Spectrum Infusion pump to provide life-saving and life-sustaining care to patients."
Baxter has had some other regulatory hiccups recently, including a recall of its Dual Luer lock caps that got the highest-risk warning label from the FDA. The medical device maker recalled the caps after finding "particular matter" loose in the devices’ packaging, the company announced earlier this month.
BAX shares were modestly down today, trading at $65.92, a 0.7% decrease, as of about 12:15 p.m.