Infusion pump alarm may fail to sound due to manufacturing defect
ICU Medical recalls approximately 93,135 Plum 360 infusion pumps due to a manufacturing defect that could prevent alarm signals from sounding. The devices were manufactured between July 2020 and December 2021.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The hazard—failure of an audible alarm in a safety-critical infusion pump—is theoretical but represents significant risk of harm if alarm malfunction prevented healthcare providers from detecting dangerous conditions. Per the rubric, risk-of-harm products without reported injury score High (3).
Plain-English summary
ICU Medical Inc is recalling approximately 93,135 Plum 360 infusion pumps distributed worldwide. The devices were manufactured between July 2020 and December 2021 and can be identified by UDI/DI M335300101.
A manufacturing defect in a supplier-provided component creates a potential that the audible signal for an alarm may not sound under certain operating conditions. Infusion pumps rely on audible alarms to alert healthcare providers to critical situations such as line occlusions, air in the line, or equipment malfunction. If the alarm fails to sound, detection of these conditions could be delayed, potentially affecting patient safety.
This recall affects Plum 360 infusion pumps used in healthcare settings worldwide. Patients and healthcare workers using these devices should be aware of this potential defect.
Additional information about the recall, including specific list numbers for affected devices and instructions for replacement or corrective measures, is available from the FDA and the manufacturer, ICU Medical Inc.
The recalled product
- Product
- 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, 30010341
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Infusion Pump
- Hazard
- alarm-failure
- missed-alert
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI M335300101
- All Plum 360 pumps manufactured between July 2020 and December 2021
Distribution
Distribution scope not specified by the agency.
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