ICU Recalls 214 Plum A+ Infusion Systems Due to Battery Error
ICU is recalling 214 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (infusion pump) where therapy interruption is possible, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU is recalling 214 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 defect where battery issues can cause an E321 error code to appear on the device.
The presence of this error code may lead to an interruption of therapy. The affected devices are identified by List number 12391 and specific serial numbers ranging from 13840001 to 13843411. The recall covers units distributed nationwide and worldwide.
Healthcare facilities and users should check their inventory for the affected serial numbers and contact ICU for further instructions on how to address the battery-related defect.
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
- 214
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 Recalls 71 Plum A+ Infusion Systems Due to Battery Error
FDA (Devices) · 2017-07-19
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- 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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