CareFusion 303 is recalling over 1 million Alaris PCU (model 8015), Alaris Syringe Modules (model 8110), and Alaris PCA Modules (model 8120) because the device labeling includes specific syringes that have not been properly validated for use with these pumps. Using unvalidated syringes can lead to inaccurate medication delivery or mechanical errors during patient-controlled analgesia or general infusions. This recall affects approximately 1,087,482 units distributed worldwide.
The use of unvalidated syringes in these infusion pumps may cause the device to deliver incorrect doses of medication or fail to recognize the syringe correctly, potentially leading to over-infusion or under-infusion of critical medications.
Manufacturer labeling update and validation guidance.
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.
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 · 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.