ICU Recalls Plum A+ Infusion Systems Due to Battery Error
ICU is recalling 7,351 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting 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 could interrupt therapy, representing a risk of harm to patients, but the source text does not report any specific injuries, illnesses, or deaths.
Plain-English summary
ICU is recalling 7,351 units of the Plum A+ Infusion Systems, a family of microprocessor-based infusion pumps used for precise delivery of therapies in clinical care. The recall is due to a potential interruption of therapy caused by battery issues that trigger an E321 error code on the device.
The affected units were distributed nationwide and worldwide. The source text does not specify the exact date of distribution or the specific clinical settings where these devices are currently in use.
Healthcare facilities and users should check their inventory against the provided list of serial numbers to identify affected units. If a device is found to be affected, it should be removed from service and the manufacturer contacted for further 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…
- Manufacturer
- ICU
- Category
- Medical Device — Infusion Pump
- Affected units
- 7,351
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 214 Plum A+ Infusion Systems Due to Battery Error
FDA (Devices) · 2017-07-19
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