ICU Medical Plum Duo Infusion Pump Software Dose Limit Issue
ICU Medical is recalling Plum Duo infusion pumps with software version 1.1.1 because a workflow may bypass the Maximum Dose Limit alert, potentially allowing unsafe medication doses to be programmed.
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: This is an FDA Class II recall involving a high-risk medication delivery device where a safety feature (Maximum Dose Limit alert) may be bypassed, creating risk of harm through potential overdose. The source explicitly states no illnesses or injuries have been reported, which per the rubric caps the score at 3 for a risk-of-harm product without reported adverse events.
Plain-English summary
ICU Medical, Inc. is recalling 1,701 units of Plum Duo infusion pumps (Item numbers 400020401, 400021001, and 400021003) with software version 1.1.1. Internal testing identified a workflow that may result in bypassing the Maximum Dose Limit alert, which is configured in the LifeShield Drug Library Manager within LifeShield Medication Management Safety Software.
The Maximum Dose Limit specifies the highest dose at which the pump can be programmed for weight or body surface area (BSA) based medication rulesets. This limit can be configured for regular Dose, Loading Dose, and Bolus Dose parameters. If the alert is bypassed, doses exceeding the intended limits could potentially be programmed into affected pumps.
The recalled pumps were distributed worldwide, including in the United States in Florida, Kentucky, Virginia, Mississippi, Massachusetts, Pennsylvania, New York, California, and Iowa, as well as in the Philippines. Specific lot and serial numbers are identified by the FDA.
Patients and healthcare providers using affected Plum Duo pumps should contact ICU Medical for information about a software update or other remedial action.
The recalled product
- Product
- ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 1,701
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 (20)
- 1) 400020401: UDI/DI 400020401
- Serial/Lot Numbers: 50000184
- UDI/DI +M335400021
- Serial/Lot Numbers: 50002748
- 50002774
- 50001647
- 50001654
- 50001601
- 50001615
- 50001651
- 50002547
- 50002577
- 50002678
- 50002689
- 50002750
- 50002751
- 50002755
- 50002773
- 50002788
- 50002798
Distribution
Part of a larger recall action
This product is one of 2 recalled by ICU Medical, Inc. 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 2 products in this recall →Related recalls
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Same hazard · dose limit bypass
See all →- HighICU Medical Plum Solos Infusion Pump Software Safety Defect Recall
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