The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1304-2025·Announced 2025-03-19

BD Alaris Systems Manager Infusion Software Affected by Programming Request Issue

BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This FDA Class I recall for infusion safety software meets the Class I threshold requiring minimum severity score of 4. The software may transmit outdated programming requests to care units, posing a risk to patient safety.

Plain-English summary

BD Alaris Systems Manager (REF 9601) is infusion safety management software used in hospitals and healthcare facilities. The FDA has identified a software issue in versions 12.5.1, 12.5.2, and earlier versions that affects patient safety.

The software may transmit outdated automated programming requests (APR) to progressive care units, which could result in incorrect infusion programming. This issue represents a Class I recall.

The product is distributed across multiple U.S. states including Arizona, California, Florida, Georgia, Illinois, Indiana, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, and Washington D.C. Healthcare facilities using this software should contact CareFusion 303, Inc. for guidance on updates or corrections.

The recalled product

Product
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Safety Software
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Software v12.5.1 or v12.5.2
  • and prior versions (4.33
  • 12.0.1
  • 12.0.2
  • 12.1
  • 12.1.2
  • 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)

Distribution

Distributed in 21 states:

Part of a larger recall action

This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same manufacturer · CareFusion 303, Inc.

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