Meta Description: BD has expanded its voluntary Class I recall for Alaris™ Pump infusion sets, adding 15 discontinued models with serious risks for critical patients.
Becton, Dickinson and Company (BD), a global medical technology leader, has announced an update to its Class I voluntary recall for BD Alaris™ Pump Module model 8100 infusion sets. Initially launched on July 8, 2025, and expanded on July 17, 2025, the recall now extends to 15 additional sets previously discontinued but potentially still in stock anywhere these products were distributed.
Key Points:
- BD’s recall stems from performance deviations that could compromise dose accuracy, posing a serious risk to vulnerable patients.
- The FDA designated the recall as Class I, indicating a high risk of patient harm or death.
- Healthcare providers are urged to transition to recommended alternatives where clinically suitable.
- BD has not received direct complaints but initiated the recall following internal testing.
In this article:
- Why is BD expanding this recall?
- What products are impacted?
- What steps should healthcare providers take?
- Frequently Asked Questions
- Conclusion
- Disclaimer
- FDA Source Link
Why is BD expanding this recall?
The update, shared on September 12, 2025, broadens BD’s Class I recall to include 15 additional infusion sets for the Alaris™ Pump Module model 8100. These sets were previously discontinued, yet eligible for market circulation within their expiration date timeframe. The manufacturer detected performance inconsistencies during internal testing, identifying scenarios potentially threatening patient safety.
The FDA categorizes this recall as Class I—the most critical classification—signaling the risk of severe health consequences or fatalities. BD stressed the heightened risk to vulnerable groups, especially neonates and critically ill patients who might rely on infusates or medications requiring precise dosing.
What products are impacted?
The affected infusion sets include models distributed across various regions, such as the United States (including Puerto Rico and Guam), Canada, South Africa, and Belgium. Although no adverse events or deaths have been directly reported, BD underscores that deviations could lead to:
- Flow rate inaccuracies affecting underdose or overdose.
- Post-occlusion bolus volume (POBV) irregularities causing bolus over-delivery.
- Delayed alarm signaling for upstream or downstream occlusions.
Customers have received a list enumerating the 15 new impacted models and suggestions for alternate infusion sets suitable for clinical substitution.
What steps should healthcare providers take?
To manage potential risks effectively, BD has initiated updated actions:
- Communicating mitigation pathways for healthcare facilities.
- Advising practitioners on transitioning to unaffected infusion pumps to maintain safe operations.
- Encouraging compliance with rigorous device monitoring protocols aligned with patient safety priorities.
Clinics, caregivers, and technical support teams are requested to promptly report concerns using BD’s Complaint Center (1-844-823-5433) or productcomplaints@bd.com. Reports detailing adverse effects can also be submitted via the FDA MedWatch Program.
Frequently Asked Questions
- What does Class I recall entail?
It signifies the highest recall risk posing severe outcomes like death, mandating urgent action from distributors and clinical teams. - Have adverse effects been documented?
While BD has reported no customer complaints so far, their internal analytics flagged the faults. - Can older Alaris sets still be safely used?
BD advocates using recommended replacements wherever viable, ensuring medication adequacy uncompromised by set variability risks.
Conclusion
BD’s step to include more products in its voluntary recall highlights their focus on proactive patient safety. Healthcare teams should prioritize alternate infusion devices or invest vigilant decision-making when using remaining recalled sets.
Disclaimer
This content aims to inform clinical professionals under regulatory lines yet excludes client-inferred legal frameworks unique-case dependent therein!
FDA Source Link
For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-voluntary-recall-certain-bd-alaristm-pump-infusion-sets