Day

June 18, 2025
18
Jun

FDA Recall: Software error may result in bypassing the Maximum Dose Limit alert

June 18, 2025
Company: ICU Medical, Inc. Date of Enforcement Report: 6/18/2025 Class: II PRODUCT ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump Recall Number: Z-1990-2025 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...
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