Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
USIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Recalling Firm: Fresenius Kabi USA, LLC
Motivo del Retiro / Peligro
TranslatedFresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
Descripción del Producto e Identificación
TranslatedIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Additional Source Details
| Field | Value |
|---|---|
| City | North Andover |
| State | MA |
| Event id | 98945 |
| Address 1 | 50 High St Ste 50 |
| Code info | Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers: |
| Postal code | 01845-2620 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 18,444 |
| Reason for recall | Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260506 |
| Initial firm notification | |
| Center classification date | 20260529 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
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 GuideQ1:What should I do immediately if I own or bought Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004?
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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Resumen
- Empresa ResponsableFresenius Kabi USA, LLC
- StatusOngoing
- Nivel de RiesgoClass I
- DistributionDomestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
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🚨 SAFETY ALERT: Fresenius Kabi USA, LLC - Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Check if your household is affected: https://therecallfile.com/es/recalls/ivenix-infusion-system-iis-large-volume-pump-model-number-lvp-0004/FDA-Z-2224-2026
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