ICU Recalls Plum A+ Infusion Systems Due to Battery-Related Therapy Interruption
ICU is recalling 10,609 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting patient 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 is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ICU is recalling 10,609 units of the Plum A+ Infusion Systems, a family of microprocessor-based infusion pumps used for precise delivery of multiple therapies in clinical care. The recall is due to a possible interruption of therapy when an E321 error code occurs, which is caused by battery issues.
The affected devices are available in single-channel and triple-channel pumping mechanism types. The recall covers units distributed nationwide and worldwide. Specific serial numbers are listed in the official recall documentation.
Healthcare facilities and users should check their device serial numbers against the provided list. If a device is affected, users should follow the instructions provided by ICU to address the battery issue and prevent therapy interruptions.
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
- 10,609
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 11971
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 Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
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- 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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