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The official notice did not include a photo. Check the product details and identifiers below.
No image published for this recall
An official Health Canada notice concerns Plum 360 infusion system with mednet. 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. Alarms on Plum 360 consist of three elements: a visual alarm indication, an audible signal, and a message that appears on the display. Plum 360 pumps test the primary alarm audible signal during the power-on sequence. If the pump detects a failure of the audible signal during power-on, the pump display will remain off and the line b drip indicator will flash, indicating the pump has failed power-on. If the audible signal fails after passing the power-on test and during the use of the pump, a situation may occur where the pump has stopped infusion and an alarm is triggered without an audible signal. The pump will remain in this state until a clinician addresses the alarm. The visual alarm indication and the message will still appear on the display. Recall start date: July 5, 2023 Published 2023-07-20.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73967
Official notice
2023-07-20
The hazard
The hazard
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. Alarms on Plum 360 consist of three elements: a visual alarm indication, an audible signal, and a message that appears on the display. Plum 360 pumps test the primary alarm audible signal during the power-on sequence. If the pump detects a failure of the audible signal during power-on, the pump display will remain off and the line b drip indicator will flash, indicating the pump has failed power-on. If the audible signal fails after passing the power-on test and during the use of the pump, a situation may occur where the pump has stopped infusion and an alarm is triggered without an audible signal. The pump will remain in this state until a clinician addresses the alarm. The visual alarm indication and the message will still appear on the display. Recall start date: July 5, 2023
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Icu Medical, Plum 360 Infusion System With Mednet.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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