ICU Recalls 180 Plum A+ Infusion Systems Due to Battery Issues
ICU is recalling 180 Plum A+ Infusion Systems because battery issues may cause an E321 error code and interrupt 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 medical device where a defect (battery issue) can cause an interruption of therapy. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as therapy interruption in a clinical setting poses a significant risk of harm, though no specific injuries are reported in the source text.
Plain-English summary
ICU is recalling 180 units of the Plum A+ Infusion Systems. These are multipurpose, microprocessor-based infusion devices available in single and triple channel configurations, used for precise delivery of therapies in clinical care.
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. The specific serial numbers for the 180 units are listed in the official recall documentation. Healthcare facilities and users should check their inventory against the provided serial number list and follow the instructions provided by ICU for the recall.
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…
- Manufacturer
- ICU
- Category
- Medical Device — Infusion Pump
- Affected units
- 180
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)
- List number: 11005
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
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
Same hazard · therapy interruption
See all →- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- ModerateDonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Fault Recall
FDA (Devices) · 2026-05-20
- ModerateDonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Defect
FDA (Devices) · 2026-05-20
- ModerateDonJoy IceMan Classic Cube cold therapy unit connector defect recall
FDA (Devices) · 2026-05-20
- HighMedline Kits with Tego Connectors Recalled Due to Silicone Seal Defects
FDA (Devices) · 2026-03-04
Similar recalls
- SeverePlum A+ & A+3 Infusion System Batteries Recalled Due to Manufacturing Defect
FDA (Devices) · 2023-05-24
- SeverePlum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect
FDA (Devices) · 2024-08-21
- HighICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction
FDA (Devices) · 2017-11-22
- SevereReplacement Battery in Plum 360 Infusion System Recalled for Capacity Loss
FDA (Devices) · 2023-05-24
- HighICU Medical Recalls Plum 360 Infusion Systems Due to Module Disengagement Risk
FDA (Devices) · 2017-08-23
- HighHospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift
FDA (Devices) · 2013-11-20