FDA-Device2026-07-22Class IIPROCESSING DEFECT
ICU Medical Plum Solo Precision IV Pump v1.0.3 recalled for potential overdose risk
What this means
In certain conditions, the Plum Solo Precision IV pump (v1.0.3) may not properly track the volume of fluid being delivered and could administer up to twice the intended amount of medication or fluid. This affects specific serial numbers of the pump.
- Check if your facility's pump matches the serial numbers listed in the recall notice
- Contact ICU Medical for instructions on obtaining a replacement or corrected unit
- Do not use affected units until corrective action is complete
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
5059 units
Manufactured in
600 N Field Dr, Lake Forest, IL, United States
Products
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2724-2026More ICU Medical recalls
- FDA-Device2026-09-23ICU Medical CADD Yellow Medication Cassette Reservoir recalled for medication leakage risk
- FDA-Device2026-09-23ICU Medical IV Sets with drip chambers recalled for black specks in fluid path
- FDA-Device2026-09-23ICU Medical IV tubing sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical IV gravity administration sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical IV tubing sets recalled for black specks in drip chambers
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