Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Franklin Lakes, NJ — Medical technology leader Becton, Dickinson and Company (BD) has announced an expanded voluntary global recall of specific Alaris™ and BD Alaris™ Pump Modules due to significant safety issues related to outdated bezel kit assemblies. This recall was revealed on July 15 and subsequently published by the U.S. Food and Drug Administration (FDA) on July 17, highlighting the risk of pump malfunctions that have already been linked to patient injuries and fatalities.
The recall focuses on pump modules that might have been serviced with previously recalled bezel kit assemblies produced between April 2011 and June 2017. These kits, which were initially recalled in 2019, include a particular plastic (FR-110) that deteriorates over time. The compromised material can result in cracked or broken bezel bosses—essential elements in pump construction—leading to risks of free flow, over-infusion, under-infusion, or total therapy interruption.
BD has reported that some hospitals and third-party service providers inadvertently utilized these faulty parts during the maintenance and repair of pump modules. Consequently, even devices that were not originally manufactured with the affected bezels may now exhibit the defect due to servicing.
“This expanded recall is a critical step to protect patient safety,” BD said in its statement. “We are urging customers to immediately inspect and remove any affected bezel kit assemblies and to take out of service any pump modules found to be compromised.”
Immediate Actions for Customers
BD advises healthcare providers to:
- Dispose of any remaining affected bezel kits.
- Review maintenance records to identify any serviced pump modules.
- Perform a visual inspection of potentially affected pumps.
- Remove affected units from service and contact BD for next steps.
Customers may access detailed instructions and FAQs on BD’s recall website or contact BD directly at 1-888-562-6018.
Reporting Adverse Events
Healthcare professionals and users are encouraged to report any complications or adverse events related to these devices to BD’s Complaint Center at 1-844-823-5433 or via email at productcomplaints@bd.com. Reports can also be submitted to the FDA’s MedWatch Program online at www.fda.gov/medwatch, or by calling 1-800-FDA-1088.
BD’s Commitment to Safety
BD, which employs over 70,000 people globally, reaffirmed its commitment to working closely with healthcare providers to ensure the safety of medical technology in clinical settings. “Our goal is to enhance outcomes, improve safety, and support frontline healthcare workers,” said Troy Kirkpatrick, BD’s Vice President of Public Relations.
The company highlighted that it is in constant communication with all impacted customers and partners globally, and it will keep offering updates and assistance during the recall process.
