Icu Medical, Inc.: Pump, Infusion
Recall Summary ICU Medical is recalling the Plum Solo Precision IV Pump (model 40001-0401) due to a software issue where the pump may fail to alert clinicians when medication delivery exceeds set limits. This could result in patients receiving incorrect doses of medication. The pump was distributed nationwide across the US and in Canada.
- Recalling firm
- ICU Medical, Inc.
- Product
- Plum Solo Precision IV Pump, 40001-0401
- Reason
- Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/999a94b1-40dd-4a1c-b05d-37b8cdfe05ac