Brand name: BD Alaris
Product recalled: BD Alaris System PC Units and Modules
Reason of the recall: Infusion pump may not operate as expected
FDA Recall date: March 10, 2020
Recall details: BD (Becton, Dickinson and Company), a leading global medical
Delay options programming;
Low Battery Alarm Failure;
Keep vein open (KVO)/End of Infusion alarms priority;
Use errors related to Customer Concentrations Programming.
Customers should review and follow the instructions in the recall letter:bd.com/alaris-system-software-recall.As previously communicated, BD is committed to seeking clearance of a comprehensive 510(k) filing for the Alaris™ System, which will remediate the issues identified in the Feb. 4, 2020 recall notification.In the interim, BD is providing important user actions in the recall notification letter to help mitigate the potential risks until these software issues are fully remediated. BD has also created a dedicated team of clinical consultants to support training for health care providers. For more information and to review all of the available resources provided by BD, please visit: bd.com/alaris-system-software-recall.Affected ProductsBD Alaris™ System PC Unit Model 8000, software versions 9.5 and prior
BD Alaris™ System PC Unit Model 8015, software versions 12.1.0 and prior
BD Alaris™ Pump Module Model 8100, software versions 12.1.0 and prior
Alaris™ Syringe Module Model 8110, software versions 12.1.0 and prior
Alaris™ PCA Module Model 8120, software versions 12.1.0 and prior
Note that some affected devices may be branded under the CareFusion name.
Check the full recall details on www.fda.gov
Source: FDA