Notice names this product. ICU Medical’s Plum Duo Precision IV Pump is named in FDA Class II recall Z-2313-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported 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. Identifying details: UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3. Units affected: 13,613. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Plum Duo Precision IV Pump
Company / brand
ICU Medical
Lot / serial / date codes
UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3
Distribution
Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Agency product description and boundaries
Plum Duo Precision IV Pump, 40002-0403
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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…