Becton Dickinson (NYSE:BDX) in its most recent fiscal year set aside $244 million to cover future product remediation costs, including the company’s work to fix its problematic Alaris infusion pumps.
The Franklin Lakes, N.J.–based company has had shipments of the pumps on hold since early this year, when FDA called for a comprehensive 510(k) submission to covers a host of software fixes needed after a Class I-level recall. Pumps are only going to health providers with an immediate medical need.
The company expects to submit the 510(k) in late Q2 or early Q3 (around spring 2021), CEO Thomas Polen said during a Nov. 5 earnings call.
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