ICU Medical Recalls Plum 360 Infusion Systems Due to Module Disengagement Risk
ICU Medical is recalling 68,559 Plum 360 Infusion Systems because the Connectivity Engine Module may disengage, causing the unit to shut down without an alarm and interrupting therapy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a high-risk medical device where a failure could interrupt therapy, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical Inc is recalling 68,559 units of the Plum 360 Infusion System, Model No. 30010. The recall is due to a potential defect where the Connectivity Engine Module may disengage from the main chassis. This disengagement can cause the unit to shut down without providing an alarm notification, which may delay the initiation of therapy or interrupt an ongoing infusion.
The affected units were distributed nationwide in the United States, including Puerto Rico and the District of Columbia, as well as to various international locations including Australia, Canada, and the United Kingdom. The source text does not specify specific dates of distribution or the exact number of units in each location.
Healthcare providers and consumers should stop using the affected units and contact ICU Medical Inc for further instructions on replacement or repair. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Plum 360 Infusion System
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 68,559
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 (1)
- Model No. 30010
Distribution
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