FDA MedWatch – BD Alaris System Software by BD:

TOPIC: BD Alaris System Software by BD: BD to Begin Remediation – Because Infusion Pump May Not Operate as Expected

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: BD will begin remediation for the February 4, 2020 BD Alaris System 1 recall through a new version of software.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The BD Alaris System allows clinicians to deliver medications, fluids and blood products through a single integrated platform that includes large volume pumps, syringe pumps and patient-controlled analgesia (PCA) modules for adult, pediatric and neonatal patients.

RECOMMENDATION: Effective today, customers can begin scheduling remediation by contacting the BD Recall Support Center at 1-888-562-6018. 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.