ICU Medical is recalling approximately 3,840 counterfeit CSB batteries used with various Plum Infusion Systems because they were not manufactured, tested, or validated by the original equipment manufacturer. These unauthorized batteries, distributed by OSI Batteries, have been reported to fail to hold a charge, which can cause the infusion pump to display battery replacement messages earlier than expected or stop working entirely. The recall affects batteries used with Plum 360, Plum A+, and Plum A+3 Infusion Systems. No injuries have been reported to date, though there are reports of the batteries failing to hold their charge.
The counterfeit batteries may fail to hold a charge, leading to sudden power failure of the infusion system. If the pump stops working during a critical medication delivery, it could result in treatment interruption and serious patient harm.
Affected batteries are identified by the ABSENCE of an ICU Medical Test Label and CE Mark on the label.
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 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.