🔍 RecallPedia

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Class I - Dangerous
🏥 Medical Devices Recalled: February 18, 2025 CareFusion 303 Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
CareFusion 303, Inc.
Reason for Recall:
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

Product Codes/Lot Numbers:

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:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1304-2025

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