Recall Z-1990-2025— ICU Medical, Inc.

Name: FDA recall Z-1990-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-22

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2025-04-22. It names one FDA 510(k) clearance: K223607. Product: ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump. Reason: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-22
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K223607 — Plum Duo Infusion SystemIcu Medical, Inc.·cleared 2023-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump

Reason for recall

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

Data sourced from openFDA. This site is unofficial and independent of the FDA.