FDA DevicesClass II
Plum Solo Precision IV Pump, 40001-0401
Published: June 17, 2026Recall ID: Z-2311-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Plum Solo Precision IV Pump, 40001-0401
Additional Source Details
| Field | Value |
|---|---|
| City | Lake Forest |
| State | IL |
| Event id | 98872 |
| Address 1 | 600 N Field Dr |
| Address 2 | N/A |
| Code info | UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3 |
| Postal code | 60045-4835 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 13,613 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260429 |
| Initial firm notification | Letter |
| Center classification date | 20260605 |
Overview
- Recalling FirmICU Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.