Plum 360 Infusion System, List Numbers: 300100405… recallZ-2430-2023 · ICU Medical Inc · initiated Jul 13, 2023
Class II Open, Classified All recalls posted in August 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Nonconforming Material/Component
What the company is doing
ICU 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 [email protected] 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 [email protected]. 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.
Recall details
- Recall number
- Z-2430-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 13, 2023
- Posted by the FDA
- Aug 18, 2023
- Recalling firm
- ICU Medical Inc
- Quantity
- 93135 devices
- Product code
- FRN
- FDA submissions
- K141789, K161469
- Distribution
- Worldwide
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
Code information (models, lots, serial numbers)
UDI/DI M335300101, All Plum 360 pumps manufactured between July 2020 and December 2021
Other devices under the same FDA submission
35 devices cleared under K141789, K161469 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Plum 1468728ICU Medical, Inc. · Set, administration, intravascular1 recall2 deaths482 reports
- Plum 1425628ICU Medical, Inc. · Set, administration, intravascular1 recall204 reports
- Plum 1425528ICU Medical, Inc. · Set, administration, intravascular1 recall164 reports
- Plum 1427329ICU Medical, Inc. · Set, administration, intravascular214 reports
- Plum 1233912ICU Medical, Inc. · Set, administration, intravascular1 recall131 reports
- ICU Medical 15247-28Icu Medical, Inc. · Set, administration, intravascular1 recall13 reports
- ICU Medical 15339-28Icu Medical, Inc. · Set, administration, intravascular1 recall9 reports
- Lifeshield 1495188ICU Medical, Inc. · Set, administration, intravascular1 recall3 reports
- ICU Medical 15256-28Icu Medical, Inc. · Set, administration, intravascular1 recall1 report
- Plum 1425128ICU Medical, Inc. · Set, administration, intravascular1 recall1 report
- ICU Medical 15951-28Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Plum 1495388Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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