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U.S. Department of Health and Human Services

Class 1 Device Recall Plum Series Infusion Systems

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  Class 1 Device Recall Plum Series Infusion Systems see related information
Date Initiated by Firm March 22, 2023
Date Posted May 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-1565-2023
Recall Event ID 91874
510(K)Number K161469  K141789  
Product Classification Pump, infusion - Product Code FRN
Product Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Code Information All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower
Recalling Firm/
Manufacturer		 ICU Medical Inc
600 N Field Dr
Lake Forest IL 60045-4835
For Additional Information Contact Technical Assistance
800-241-4002
Manufacturer Reason
for Recall		 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
FDA Determined
Cause 2		 Under Investigation by firm
Action ICU medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 03/22/2023 to its direct and indirect consignees by mail. The notice explained the issue and the hazard and requested the following: Clinical Users: Whenever possible, keep the pump plugged into AC power. Before disconnecting the pump from AC power, please ensure that the battery is fully charged. Closely monitor the Battery Status Indicator while the pump is disconnected from AC power. Additionally, have a backup pump available when infusing critical medications. Biomedical Engineering: You may replace affected batteries with a new CSB battery until corrected batteries are available. Please do not use a replacement battery with corroded battery terminals. 1. Identify all affected batteries in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification and proposed mitigations. 2. Complete and return the attached Response Form to icumedical5967@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to icumedical5967@sedgwick.com.
Quantity in Commerce 28656 units
Distribution worldwide
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = Hospira, Inc
510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.
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