The FDA has designated both recalls as Class I, as the agency has received reports of several serious injuries associated with the recalled devices.
The Alaris model 8100 modules were manufactured between April 2011 and June 2017. Both products were formerly marketed under the CareFusion brand, which BD acquired in March 2015.
BD said it notified clinicians in April that the process used to manufacture the bezel assemblies in the recalled Alaris model 8100 pump modules resulted in weakened plastic. Over time, further weakening of the plastic could to lead to separation of the bezel posts, as well as other damage to the bezel, which may result in free-flow, over-infusion, under-infusion or interruption of infusion, according to the company.
The April 15, 2019, notice instructed customers to inspect all recalled pumps during annual maintenance checks and to remove the pump from service if damage is found. Now the company is telling customers that until the affected bezels are replaced, they should inspect both Priority 1 and Priority 2 pumps as soon as feasible.
No products manufactured after June 2017 are affected by this recall, including the BD Alaris PCU and BD Alaris Pump Module that were introduced in March 2018.
The company recalled the Alaris infusion sets for pump model 8100 on May 9, 2019, saying that an incomplete occlusion can occur on the pumping segment that can lead to unintended delivery of medication when the pump module is not running, over-infusion and the potential for serious patient injury.
BD is instructing customers to destroy all Alaris infusion sets affected by this recall. A full list of affected product codes, lot numbers and expiration dates can be found here.