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U.S. Department of Health and Human Services

Class 1 Device Recall Plum Infusion System nonOEM battery manufactured by CSB

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 Class 1 Device Recall Plum Infusion System nonOEM battery manufactured by CSBsee related information
Date Initiated by FirmOctober 22, 2024
Date PostedNovember 21, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0482-2025
Recall Event ID 95586
Product Classification Pump, infusion - Product Code FRN
ProductAllegedly 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
Code Information 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
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
600 N Field Dr
Lake Forest IL 60045-4835
For Additional Information ContactMrs. Mary J. Ferreira
845-907-1429
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionICU Medical issued an "URGENT MEDICAL DEVICE SAFETY ALERT" on 10/22/2024 via letter. The notice explained the issue, potential risk of use, and requested that all affected products be removed from use and destroyed. Distributors were directed to forward the notice to their customers. For further inquiries: Additional information or technical assistance: Technical Support, 1-800-241-4002 (M-F, 8:00 am 6:00 pm CT); To report adverse events or product complaints: Global Complaint Management, 1-844-654-7780 (M-F, 8:00am 5:00pm CT) or ProductComplaintsPP@icumed.com.
Quantity in Commerce3840
DistributionWorldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingdom, and Uruguay.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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