Medical technology manufacturer BD has announced an expanded voluntary recall of certain BD Alaris™ Pump Module model 8100 infusion sets. This recall affects clinical, quality, and regulatory teams worldwide, emphasizing new safety risks and performance deviations observed during internal testing.
What changed?
Initiated in the United States as a Class I voluntary recall on July 8, 2025, and expanded on July 17, 2025, the recall now includes 15 additional infusion sets. These sets had been discontinued but could still be in inventory due to active expiration dates. BD has identified performance concerns under specific use cases that were not described in the product’s user manual. The deviations may pose significant risks, including incorrect infusion delivery rates and alarm delays. Specific patient groups, including neonates and critically ill individuals, face increased safety concerns.
Key issues identified by BD
According to BD, internal testing revealed that the discrepancies in function stem from features such as filters and other in-line pump design components. This impacts critical aspects of infusion accuracy and patient safety, including:
- Flow rate and loading bolus dose accuracy, which could result in over or under-infusion.
- Upstream and downstream occlusion alarm delays, leading to slower responses to blockages.
- Post-occlusion bolus volume (POBV) over-infusion.
The manufacturer has confirmed no complaints reported so far regarding these performance deviations. Nonetheless, adverse events related to medication dose errors are severe and require immediate attention due to potential patient harm or fatality risks.
Distribution and affected regions
These affected infusion sets were distributed across the United States, including territories such as Guam and Puerto Rico, as well as Canada, Belgium, and South Africa.
Corrective actions shared by BD
Customers were issued an update on September 11, 2025, detailing the corrective actions and risk mitigations in response to these findings. BD has recommended switching to alternative BD Alaris™ Pump infusion sets that meet the performance thresholds described in the user manual. A comprehensive list of affected products is now available on BD’s official website, alongside detailed recommendations for managing inventory and reporting complaints.
For immediate support, BD’s customer service helpline is available at 1-888-562-6018 during business hours (Monday – Friday, 9 a.m. to 6 p.m. ET). Reports of adverse reactions can also be directed to BD’s Complaint Center at 1-844-823-5433 or via email at productcomplaints@bd.com.
FDA adverse event reporting
Health organizations and individuals experiencing adverse reactions with these products are urged to notify the FDA through its MedWatch Program:
- Online: Complete and submit the form at www.fda.gov/medwatch/report.htm.
- Phone: Call 1-800-FDA-1088 (1-800-332-1088).
- Regular Mail: Download forms at www.fda.gov/MedWatch/getforms.htm or request a pre-addressed reporting form by fax at 1-800-FDA-0178.
Takeaways
The expanded recall underscores critical safety concerns around BD Alaris™ Pump infusion sets. Healthcare providers must assess their inventories and immediately implement BD’s recommended corrective measures. Vigilance in managing these devices is key to minimizing risks while ensuring compliance with new updates.
Disclaimer
This article provides factual information based on official reports and FDA communications. It is intended for clinical and regulatory professionals and does not constitute legal advice.