ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
ICU is recalling Plum A+ Infusion Systems because battery issues can cause an E321 error code, potentially interrupting therapy.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (interruption of therapy) where injury has not yet been reported, fitting the criteria for a score of 3.
Plain-English summary
ICU is recalling the Plum A+ Infusion Systems, a family of microprocessor-based infusion pumps used for precise delivery of multiple therapies in clinical care. The recall involves 184,399 units distributed nationwide and worldwide.
The recall is due to a possible interruption of therapy when an E321 error code occurs. This error is caused by battery issues within the infuser. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities and users should check their serial numbers against the list provided in the official recall notice (Z-2679-2017) to determine if their devices are affected. The source text does not specify a particular corrective action or consumer instruction beyond the identification of the defect.
The recalled product
- Product
- The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
- Manufacturer
- ICU
- Category
- Medical Device — Infusion Pump
- Affected units
- 184,399
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by ICU under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · ICU
See all →- HighICU Recalls 71 Plum A+ Infusion Systems Due to Battery Error
FDA (Devices) · 2017-07-19
- HighICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
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- HighICU Recalls Plum A+ Infusion Systems Due to Battery-Related Therapy Interruption
FDA (Devices) · 2017-07-19
- HighICU Recalls Plum A+ Infusion Systems Due to Battery Error
FDA (Devices) · 2017-07-19
- HighICU Recalls 214 Plum A+ Infusion Systems Due to Battery Error
FDA (Devices) · 2017-07-19
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