The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.
BD (Becton, Dickinson and Company) issued a voluntary recall related to certain Alaris and BD Alaris Pump Modules that may have been serviced with previously recalled bezel kit assemblies.
BD is issuing this voluntary recall notice to reiterate that certain bezel kit assemblies that were manufactured between April 2011 and June 2017 and previously recalled in 2019 should not be used for service with the Alaris and BD Alaris Pump Module, according to a company announcement.
BD notes that it became aware via customer complaints of customer/third-party usage of affected bezel kit assemblies to service Alaris and BD Alaris Pump Modules. These affected bezel kit assemblies were manufactured with a specific type of plastic material that weakens over time, leading to the potential of separated and/or broken bezel bosses that can cause free flow, over infusion, under infusion, or interruption of infusion.Â
This recall has been associated with incidents of serious injury and patient death, according to the company.
The previous field action impacted bezel kit assemblies manufactured with the specific type of plastic material (FR-110 bezels) and used to service Alaris and BD Alaris Pump Modules (8100). However, as pump modules not originally manufactured with the affected bezel assembly may have been serviced by customers or a third party with the recall-affected bezel spare part, this recall is inclusive of all Alaris and BD Alaris Pump Modules.
BD is instructing customers to immediately dispose of any affected bezel kit assemblies remaining in their possession. BD is also instructing customers to check their records to determine if any of their pump modules may have been serviced with affected bezel kit assemblies and, if so, to perform a visual inspection of the bezel. If an affected bezel is found, the pump should be removed from service, and customers should contact BD for further instructions.
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