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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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Critical RiskFDA Device
Medical Devices

Plum Infusion System Counterfeit Batteries Recalled for Power Failure Risk

Agency Publication Date: November 21, 2024
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Summary

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.

Risk

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.

What You Should Do

  1. This recall involves counterfeit CSB batteries used in ICU Medical Plum 360, Plum A+, and Plum A+3 Infusion Systems distributed by OSI Batteries.
  2. Identify affected batteries by inspecting the label: recalled units do NOT have an ICU Medical Test Label or a CE Mark, and they feature a yellow side label with date codes ranging from W2401xxxx to W2406xxx.
  3. See the Affected Products section below for the full list of affected pump model (list) numbers.
  4. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Counterfeit CSB Batteries for Plum Infusion Systems
Model / REF:
30010
11005
11971
12391
12618
20678
20679
20792
60529
12348
1197
Date Ranges: W2401xxxx - W2406xxx (Date code found on yellow label on side of battery)

Affected batteries are identified by the ABSENCE of an ICU Medical Test Label and CE Mark on the label.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95586
Status: Active
Manufacturer: ICU Medical, Inc.
Sold By: OSI Batteries
Manufactured In: United States
Units Affected: 3840
Distributed To: Nationwide

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.

Find an Attorney

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.