Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 30
Summary
The FDA issued a Class II for Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100 by ICU Medical Inc. Reason: 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 .
Details
Source
Device Recall
External ID
Z-2430-2023
Action Date
2023-08-30
Status
Ongoing
Category
device
Product Description
Plum 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
Lot/Code Info: UDI/DI M335300101, All Plum 360 pumps manufactured between July 2020 and December 2021
Quantity Affected: 93135 devices
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.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-13
Company
Lake Forest, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ICU Medical Inc has 95 FDA actions in our database, including 85 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ICU Medical Inc have FDA actions?
ICU Medical Inc has 95 FDA actions in our database, including 85 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2430-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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