Icu Medical, Inc.: Pump, Infusion
Recall Summary ICU Medical is recalling certain Plum Duo Infusion Pumps (model v1.2.3, Item Numbers 400020401 and 400020403) distributed nationwide in the US and Canada. Under specific circumstances, these pumps may fail to properly track the volume of medication being delivered and could administer up to twice the intended amount. This is a Class II recall, indicating a serious situation that may cause adverse health effects.
- Recalling firm
- ICU Medical, Inc.
- Product
- ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
- Reason
- In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3b2b1cde-19b5-4926-b487-907eaf6ebf84