BD Alaris Pump Module model 8100 used with a subset of compatible pump infusion sets

  • Pump performance variations compared to the performance described in the user manual could impact infusion delivery
  • Company: BD
  • Medical Devices
  • FDA
  • September 12, 2025

Product details

  • BD Alaris Pump Module model 8100 used with a subset of compatible pump infusion sets

Company announcement

BD expanded a Class I recall of certain BD Alaris™ Pump Module model 8100 infusion sets due to performance variations compared to the user manual.

The affected products were distributed nationwide in the United States, including Guam and Puerto Rico, and in Canada, Belgium and South Africa.

The issue could impact infusion delivery, with a higher risk to vulnerable patient populations. No complaints have been received to date.

Risk:

The affected products have the potential to result in patient death or serious adverse events, with a particular higher risk to vulnerable patient populations such as neonates and critically ill patients.

Impacted states: Nationwide

Contact

For more information, call 1-844-823-5433.

View the original FDA notice

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