Official recall notice
FDA DeviceClass IINotable
FDA Recall: Plum Duo Precision IV Pump, 40002-0403
- Recall date
- 2026-06-17
- Brand
- ICU Medical, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
13,613
Product description
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.