Affected Alaris products may have been serviced with previously recalled bezel kit assemblies. BD in 2019 recalled those kit assemblies manufactured between April 2011 and June 2017. They should not be used for service with the Alaris and Alaris Pump Module.
BD said in a news release that it became aware of customer/third-party usage of the affected kits through customer complaints. Affected bezel kit assemblies were manufactured with a specific type of plastic material that weakens over time. This can lead to potential separation and/or broken bezel bosses that can cause free flow, over-infusion, under-infusion or interruption of infusion. This recall has been associated with incidents of serious injury and patient death.
The previous field action impacted bezel kit assemblies manufactured with the FR-110 bezels plastic material. As pum modules not originally manufactured with this assembly have been serviced by customers or a third party with the recall-affected bezel spare part, this recall is inclusive of all Alaris and Alaris Pump Modules.
BD told customers to immediately dispose of affected bezel kits and to check records for servicing with those affected kits. If they find an affected bezel, they should remove the pump from service and contact the company.
More about the BD Alaris system
The Alaris system faced a series of issues over the past few years, going back to a Class I recall in early 2020. That recall centered around multiple system errors, software errors, and use-related errors. It led to a long-term shipping hold enacted that year.
BD cut its financial outlook for 2020 after initiating the shipping hold. The company applied for a new FDA clearance for the pumps in April 2021. It started a remediation effort in July 2021.
In August 2022, a federal judge in New Jersey ruled that a lawsuit against BD over how it communicated company performance amid its Alaris problems may proceed.
BD resumed Alaris distribution after receiving updated FDA clearance in July. Last December, BD reached an agreement with the SEC to resolve an investigation related to its Alaris system. It agreed to pay $175 million to the SEC. That added to an $85 million settlement to resolve a class action suit in New Jersey about a year prior.
