The US Food and Drug Administration (FDA) has classified the recall of Alaris infusion pumps of Becton Dickinson (BD)/Carefusion 303 as Class 1, which is the most dangerous category of recall.
The pumps, which include BD Alaris Syringe Module, BD Alaris PCU, and Alaris PCA Module, are being recalled over compatibility issues with Cardinal Health Monoject Syringes.
Alaris infusion pumps are said to be modular pump systems designed to administer drugs or other fluids. These pumps are validated for usage with Monoject syringes.
The rebranding of the syringes from the Covidien Monoject to the Cardinal Health Monoject has changed the dimensions of the syringes.
According to the FDA, it is not approved to use BD Alaris Syringe and PCA modules with Cardinal Health-branded Monoject syringes.
The pump may malfunction or estimate the volume of liquid in the syringe inaccurately when one of these new syringes is used with the old syringe settings. This can cause therapy delays as well as over- and under-infusions, the American health regulator said.
When using the BD Alaris Syringe and PCA Modules with incompatible syringe sizes and models, the syringe pump’s performance may be impacted, potentially leading to delayed occlusion alert generation, erroneous fluid delivery, and other issues.
As of now, there have been 13 different cases of injuries with no death reports.
BD is recalling the pumps distributed between 19 June 2004 to 22 September 2023, with 8110, 8015, and 8120 model numbers.
The process started on 15 September 2023 and the medical technology company has recalled 220,120 syringe pump and PCA modules and 867,362 PCU modules in the US.
FDA said that the healthcare providers who use the affected Alaris Pump System with Cardinal Health Monoject syringes are potentially at risk.
In addition, patients who get fluids or medications via the affected Alaris Pump systems with Cardinal Health Monoject syringes can also be affected.
BD has issued an Urgent Medical Device Labeling Correction to all customers to stop the use of affected devices and replace the current compatibility lists with the updated ones.
