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.
According to a news release, BD will release the Alaris system software version 12.1.2 and associated ancillary software to remediate the affected software under FDA guidance.
Effective today, customers can begin scheduling remediation with the software being made available at no cost. It is expected to remediate the issues identified in the Feb. 4, 2020, recall and provide programming, operational and cybersecurity updates to affected devices, although the software update has not been reviewed or cleared by the FDA.
BD submitted a 510(k) submission to the FDA for the Alaris system in April of this year in an effort to bring the system’s regulatory clearance up to date. That submission includes the software update.
“Frontline clinicians continue to rely on the BD Alaris system to deliver medications, fluids and blood products to support the care of their patients,” BD worldwide president of medication management solutions Michael Garrison said in the release. “This remediation is a positive step forward for our customers while the FDA reviews our 510(k) submission.”
