Icu Medical, Inc.: Pump, Infusion
Recall Summary ICU Medical is recalling the Plum Solo Precision IV Pump (v1.0.3, Item Number 400010401) distributed nationwide in the US and Canada. Under certain conditions, the pump may fail to reduce the displayed infusion volume and could deliver up to twice the intended amount of medication. This is a Class II recall affecting infusion pumps used in medical settings.
- Recalling firm
- ICU Medical, Inc.
- Product
- ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; 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/642e6bb9-d4e7-45fe-92c7-70a2d5bd5043