ICU Recalls 71 Plum A+ Infusion Systems Due to Battery Error
ICU is recalling 71 Plum A+ Infusion Systems because a battery issue can trigger 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. The hazard involves a potential interruption of therapy, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
ICU is recalling 71 units of the Plum A+ Infusion Systems. These are microprocessor-based infusion pumps used for precise delivery of multiple therapies in clinical care settings. The devices are available in single and triple channel pumping mechanism types.
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 affected units were distributed nationwide and worldwide.
Healthcare providers and consumers should check their serial numbers against the list provided in the official recall notice. If a device is affected, it should be removed from service and the recalling firm contacted for instructions.
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
- 71
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
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See all →- HighICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
FDA (Devices) · 2017-07-19
- HighICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
FDA (Devices) · 2017-07-19
- 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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