Accueil/Tous les Rappels/FDA-Z-2313-2026
FDA DevicesClass II

Plum Duo Precision IV Pump, 40002-0403

Publié le: 17 juin 2026ID du rappel: Z-2313-2026Catégorie: Dispositifs MédicauxPays: États-Unis
US
Medical DeviceFDA DevicesUSUS

Plum Duo Precision IV Pump, 40002-0403

Recalling Firm: ICU Medical, Inc.

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Motif du rappel / Danger

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.

Description du produit & Identification

Plum Duo Precision IV Pump, 40002-0403

Additional Source Details

FieldValue
CityLake Forest
StateIL
Event id98872
Address 1600 N Field Dr
Address 2N/A
Code infoUDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3
Postal code60045-4835
Report date20260617
Product typeDevices
Product quantity13,613
Reason for recallUnder 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 mandatedVoluntary: Firm initiated
Recall initiation date20260429
Initial firm notificationLetter
Center classification date20260605

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Plum Duo Precision IV Pump, 40002-0403?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Aperçu

  • Entreprise responsableICU Medical, Inc.
  • StatusOngoing
  • Niveau de risqueClass 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.
Recall Hazard Severity
High Alert (Class I)
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🚨 SAFETY ALERT: ICU Medical, Inc. - Plum Duo Precision IV Pump, 40002-0403

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https://therecallfile.com/fr/recalls/plum-duo-precision-iv-pump-40002-0403/FDA-Z-2313-2026
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