Reported Nov 27, 2024 · Ongoing

Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion…

ICU Medical, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ICU Medical, Inc. · 600 N Field Dr · Lake Forest, IL · 60045-4835

Is this the product you have?

  • Allegedly counterfeit batteries manufactured by CSB batteries
  • being used with Plum Infusion Systems
    • Plum 360" Infusion System
    • Pump List Number 30010
    • Plum A+ & Plum A+3" Infusion Systems
  • Pump List Numbers
    • 11005
    • 11971
    • 12391
    • 12618
    • 20678
    • 20679
    • 20792
    • 60529
    • 12348
    • 1197
Lot codes and dates
  • All batteries WITHOUT
  • the following information on the label
    • 1) ICU Medlcal Test Label
    • 2) CE Mark
    • and WITH a Date code (yellow
  • label found on side of battery)W2401xxxx - W2406xxx
Amount recalled
3840

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Stop using this product now

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.