Becton Dickinson and its CareFusion unit are removing certain Alaris infusion sets from hospitals after federal regulators said updated tests show pumps can deliver less medication than programmed, especially at slow drip rates.
Why the FDA escalated the recall
The Food and Drug Administration identified the action as a Class I recall—the agency’s most serious category—because inaccurate infusions can cause injury or death. BD told customers that sets with restrictive components, such as filters, microbore tubing, or certain check valves, may not meet previously published performance curves.
Problems appear most often when nurses program rates under 1 milliliter per hour or when bolus volumes fall at or under 5 milliliters. BD said it had not received reports of deaths tied to the issue as of August 19, but clinicians might miss the pump as a cause of sudden vital-sign changes.
What patients and families should ask
If you or a loved one is on a continuous infusion at home or in a skilled-nursing facility, ask whether the setup uses Alaris Pump Module model 8100 sets affected by the letter. Non-Alaris pumps are not part of this removal.
Request written confirmation from the facility that it swapped to cleared tubing and updated Guardrails Suite MX software if your hospital IT department mandates a minimum version. Keep the nurse call button within reach if you feel dizziness, uncontrolled pain, or withdrawal symptoms after a pump change.
Hospital actions underway
Materials BD posted to customers list specific catalog numbers to quarantine and return through the company’s field action. Biomedical engineering teams are revising drug libraries to flag low-rate orders that previously relied on the overstated performance data.
Pharmacy leaders are double-checking high-risk drugs—insulin, heparin, chemotherapy, and sedatives—where small volume errors matter most. Some systems are temporarily banning microbore tubing on Alaris channels until replacements arrive.
How this differs from earlier Alaris warnings
BD had disclosed infusion accuracy questions in prior field notices, but the October update replaces older performance tables entirely. Facilities that cached the previous memo need to substitute the new tables in policy binders and electronic health record prompts.
The FDA’s public bulletin links to BD Medical Affairs for clinical questions and to technical support at 866-488-1408 for logistics. Keep lot numbers from removed sets for accountability logs.
At-home caregivers
Home-infusion patients should not attempt to modify tubing themselves. Call your infusion provider’s 24-hour line if you hear unexpected pump alarms or see “air in line” messages after a set change. Document the time and drug involved; that information helps clinicians decide whether to switch devices.
Insurance appeals for alternate pumps may require a physician statement that the recall leaves no safe Alaris configuration for your prescription. Start that paperwork early if your supplier warns of back orders on replacement sets.