Becton, Dickinson and Company (BD) has provided update on two voluntary recalls related to certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 and certain model codes and lot numbers of the Alaris Pump Infusion Sets used with the Alaris Pump Model 8100.
BD has already notified customers affected by these recalls. Both products were formerly marketed under the CareFusion brand, which BD acquired in March 2015.
Both actions have been designated as a Class I recall by the U.S. Food and Drug Administration (FDA). Both recalls have been associated with medical device reporting (MDR) submissions, several of which are associated with serious injuries.
Alaris Pump Module Model 8100
In a recall notification sent on April 15, 2019, BD informed clinicians that the bezel assemblies in the Alaris pump modules subject to this recall expansion were manufactured with a specific type of plastic material. The company conducted an investigation and determined that the bezel manufacturing process resulted in weakened plastic. Over time, further weakening of the plastic has the potential 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.
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.
BD is contacting the customers affected by the Alaris Pump Module Model 8100 bezel recall to schedule replacement of bezel assemblies. On April 15, 2019, the BD customer notification instructed customers to inspect all pumps included in this action during the annual preventive maintenance, and if damage is found, the pump should be removed from service and BD should be contacted. The revised recall notification indicates that until the bezels affected by this recall are replaced, customers should inspect both Priority 1 and Priority 2 pumps as soon as feasible. In addition to posting the updated recall notification on BD’s website, this updated notification will be sent to all customers by July 31, 2019.
There are no changes to the affected product list. Customers should continue to refer to the attachments included in the recall notification issued on April 15, 2019. – NS Medical Devices