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 SystemPump List Number 30010Plum A+ & Plum A+3" Infusion Systems
- Pump List Numbers
1100511971123911261820678206792079260529123481197
- Lot codes and dates
- All batteries WITHOUT
- the following information on the label
1) ICU Medlcal Test Label2) CE Markand 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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