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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 Systemsee related information
Date Initiated by FirmJuly 13, 2023
Date PostedAugust 18, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2430-2023
Recall Event ID 92630
510(K)NumberK141789 K161469 
Product Classification Pump, infusion - Product Code FRN
ProductPlum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 300103414, 300104213, 300105413, 300105713, 300106313, 300106513, 300106581, 300107813, 300107814, 300108513, 300108813, 300108814, 300109913; infusion pump
Code Information UDI/DI M335300101, All Plum 360 pumps manufactured between July 2020 and December 2021
Recalling Firm/
Manufacturer		 ICU Medical Inc
600 N Field Dr
Lake Forest IL 60045-4835
For Additional Information ContactSedgwick
877-860-6370
Manufacturer Reason
for Recall		Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionICU Medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 07/13/2023 via traceable mailing. The notice explained the issue, potential risk, and requested the following: Actions for Clinical Users: If your Plum 360 pump does not power on or indicates an Audio Alarm failure, please remove the pump from use and send the pump to Biomedical Engineering. Actions for Biomedical Engineering: If you have Plum 360 pumps with Audio Alarm failures, please contact ICU Medical. 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and required actions. 2. Complete and return the attached Response Form to icumedical8320@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to icumedical8320@sedgwick.com. A similar notice was distributed specifically to consignees of instruments that were serviced which lists the specific serial numbers. The issue, potential risk, and actions are the same as the general notice.
Quantity in Commerce93135 devices
DistributionWorldwide
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.
510(K) Database510(K)s with Product Code = FRN
510(K)s with Product Code = FRN
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