Distribution Hold of the BD Alaris™ System Update

Notification

The information on this page is applicable to U.S. Customers only.

BD is committed to providing safe and secure products to our customers given their important benefits to patient health. As such, in April, 2021, BD announced it submitted a 510(k) notice to the U.S. Food and Drug Administration (FDA) for the BD Alaris™ System, which includes all modifications to the Alaris™ System since its last 510(k) clearance, implements updated features, and includes remediations intended to address the issues identified in the February 4, 2020 recall.

After consultation with FDA, BD is pleased to announce the release of Alaris™ System software v12.1.2 and associated ancillary software as part of our medical necessity program to remediate the issues in the February 4, 2020 recall letter. Please note that this device has not been cleared by FDA, and any FDA determination regarding the device may take several months to over a year and may not result in a cleared product. Additional details related to software version 12.1.2 can be found here.

BD’s Certificate of Medical Necessity Program (CMN)

As a result of the alignment with FDA for the BD Alaris software version 12.1.2, BD will continue the Certificate of Medical Necessity Program (CMN) which provided existing customers with Alaris™ System devices the ability to request limited shipment of BD Alaris™ System software compatible devices.

Under the CMN program, BD can:

Support existing customers with their immediate medical need that requires a limited shipment or with replacement of aged devices with new devices including software v12.1.2.  As a result, we have established a process by which existing customers with Alaris™ System devices may request limited shipment of the BD Alaris™ System software compatible devices upon certification of medical necessity. The following situations may qualify for medical necessity:

  • Increase in active beds due to 1) flu season 2) other seasonal higher occupancy rates or 3) emergent public health events (e.g., coronavirus)
  • Expansion of existing units (e.g., additional beds to ICUs) and new hospital wards or wings where infusion system workflow compatibility and/or interoperability are essential to patient care
  • Replacement of aged devices with new devices including software v12.1.2.

Additionally, your clinical leadership may identify other medical needs that require limited shipment of BD Alaris™ System infusion pumps. If you would like to place an order under the CMN program, please contact your BD representative to request limited shipment based on medical necessity. Please review our process below and full customer letter.

  • Step 1: Communicate your need for Alaris™ infusion pumps to your BD Alaris™ representative
  • Step 2: Your BD Alaris™ representative will provide a cover letter and Certificate of Medical Necessity
  • Step 3: Identify your quantities needed, sign the certificate and return to your BD Alaris™ representative
  • Step 4: BD’s Medical Affairs team may contact you with further questions
  • Step 5: Your BD Alaris™ representative will notify you of the decision

Initiate software remediation to address the issues in the February 4, 2020 software recall. BD will update affected devices with BD Alaris™ System software v12.1.2 and ancillary software at no charge. If you would like to initiate scheduling of this software remediation:

  • Please complete the enclosed Remediation Acknowledgement Form and return to SupportCenter@bd.com.
  • Contact the BD Recall Support Center at 1-888-562-6018 to schedule remediation.

BD is committed to our core values of continuous improvement and doing what is right to fulfill our purpose of Advancing the world of health.  We fully stand behind the safety and clinical benefits of the Alaris™ System and we are committed to continuing our service activities, remediations, technical support, and repairs.

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