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U.S. Department of Health and Human Services

Class 2 Device Recall Plum 360 Infusion System

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  Class 2 Device Recall Plum 360 Infusion System see related information
Date Initiated by Firm October 30, 2017
Create Date November 16, 2017
Recall Status1 Terminated 3 on August 28, 2019
Recall Number Z-0101-2018
Recall Event ID 78312
510(K)Number K161469  
Product Classification Pump, infusion - Product Code FRN
Product Plum 360 Infusion System, List number 30010.
Code Information All devices with software v15.10.00.010
Recalling Firm/
Manufacturer		 ICU Medical Inc
600 N Field Dr
Lake Forest IL 60045-4835
Manufacturer Reason
for Recall		 (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued letters dated 10/30/2017 via UPS on 10/30/2017 notifying their customers of the two issues.
Quantity in Commerce 21,461 devices
Distribution Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = Hospira, Inc
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