Icu Medical, Inc.: Pump, Infusion
Recall Summary ICU Medical is recalling Plum Duo Infusion Pumps (model 40002-0401) because under certain conditions, the pump may fail to display a soft limit alert and will not notify clinicians of a violation before starting medication delivery. This could result in patients receiving more or less medication than intended. The recall affects units distributed nationwide in the US and Canada.
- Recalling firm
- ICU Medical, Inc.
- Product
- Plum Duo Infusion Pump, 40002-0401
- 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/aa90c38b-e384-4936-a457-5ad7c2cdc739