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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

CareFusion 303, Inc.: BD Pyxis QFill Replenishment Station Recalled for Software Labeling Error

Agency Publication Date: August 30, 2024
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Summary

CareFusion 303, Inc. has recalled several units of the BD Pyxis QFill Replenishment Station, models 138904-01 and 155197-01, due to a software defect. This issue can cause the system to print an incorrect storage bin number on medication restock labels when the medication is stored in a non-CUBIE location. There are 15 specific units affected by this recall. If medication is placed into the wrong bin because of an incorrect label, it could lead to patients receiving the wrong medication or the wrong dosage. Consumers should contact the manufacturer immediately for guidance on software updates or corrections.

Risk

The software error leads to the printing of incorrect storage locations on pharmacy labels. This creates a high risk of medication being stocked in the wrong bins, which could result in hospital staff inadvertently administering incorrect medications to patients, potentially leading to serious adverse health events or drug interactions.

What You Should Do

  1. Check your facility's equipment to see if you are using the BD Pyxis QFill Replenishment Station (REF: 138904-01) or the BKIT BD Pyxis QFill Replenishment Station (REF: 155197-01).
  2. Verify the serial number on your device. For model 138904-01, affected serials are 44210411, 43880801, and 44227426. For model 155197-01, affected serials are 16056243, 16068264, 16082950, 16142772, 16192674, 16208218, 16208219, 16284106, 16346254, 16388826, 16388833, and 16623139.
  3. If you identify an affected unit, use extreme caution when restocking medication in non-CUBIE locations and manually verify that the medication matches the intended bin location regardless of the printed label.
  4. Contact CareFusion 303, Inc. at 10020 Pacific Mesa Blvd, San Diego, CA 92121-4386 to report your unit and receive instructions for the required software fix.
  5. Notify your healthcare provider or pharmacy administration if you believe medications were stocked incorrectly using these labels.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer corrective action and software monitoring

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BD Pyxis QFill Replenishment Station (REF: 138904-01)
Model / REF:
138904-01
Lot Numbers:
44210411
43880801
44227426
Product: BKIT BD Pyxis QFill Replenishment Station (REF: 155197-01)
Model / REF:
155197-01
Lot Numbers:
16056243
16068264
16082950
16142772
16192674
16208218
16208219
16284106
16346254
16388826
16388833
16623139

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95070
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Authorized hospital and pharmacy distributors
Manufactured In: United States
Units Affected: 3 units
Distributed To: California, Florida, Kansas, Minnesota, New Jersey, New York, Pennsylvania
Agency Last Updated: July 1, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.