ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
ICU is recalling 7,848 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 malfunction (battery issue) can interrupt therapy, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
ICU is recalling 7,848 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 potential interruption of therapy when an E321 error code occurs, which is caused by battery issues.
The affected devices were distributed nationwide and worldwide. The source text does not specify specific dates of distribution or the exact number of patients affected. No illnesses or injuries are reported in the source text.
Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice (Z-2680-2017) to determine if their units are affected. Users should contact ICU for instructions on how to proceed with 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
- 7,848
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
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