Icu Medical, Inc.: Pump, Infusion
Recall Summary ICU Medical is recalling the Plum Duo Precision IV Pump (model 40002-0403) due to a software issue that may prevent the pump from alerting clinicians when a soft limit is violated before delivery begins. This could result in patients receiving incorrect medication doses—either too much or too little. The pump has been distributed nationwide in the US and Canada.
- Recalling firm
- ICU Medical, Inc.
- Product
- Plum Duo Precision IV Pump, 40002-0403
- 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/4395aa17-22df-4aca-92e9-7e97982e42da