BD (NYSE:BDX) announced today that it will begin remediation for a 2020 Class I-level recall of its Alaris infusion system.
Franklin Lakes, N.J.–based BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes, with pumps only going to health providers with immediate medical needs.
The company has a new software version to fix errors related to System Error Code 255-XX-XXX, delay options programming, low battery alarm failure, keep vein open/end of infusion alarms priority, and user errors related to customer concentrations programming.
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