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BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units.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.
What this means for you
Illness, injury, or structural failure has been reported. 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 The software may transmit outdated programming requests to care units, posing a risk to patient safety.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The software may transmit outdated automated programming requests (APR) to progressive care units, which could result in incorrect infusion programming.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.
- Hazard
- software-malfunction
- incorrect-infusion-programming
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:
- AZ
- CA
- DC
- FL
- GA
- IL
- IN
- MI
- MO
- NC
- NJ
- NY
- OH
- OR
- PA
- SC
- TX
- UT
- VA
- WA
- WI
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