FDA DevicesClass II

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

Publicado: 8 de abril de 2026ID de Retiro: Z-1734-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

Recalling Firm: Civco Medical Instruments Co. Inc.

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Motivo del Retiro / Peligro

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

Descripción del Producto e Identificación

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

Additional Source Details

FieldValue
CityKalona
StateIA
Event id98513
Address 1102 1st St S
Code infoUDI-DI: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840
Postal code52247-9589
Report date20260408
Product typeDevices
Product quantity20 units
Reason for recallThere was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260302
Center classification date20260401

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 eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152?

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 ResponsableCivco Medical Instruments Co. Inc.
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionUS States: OH, PA, WA. China.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: Civco Medical Instruments Co. Inc. - eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

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https://therecallfile.com/es/recalls/etrax-needle-system-starter-kit-18g-for-aurora-trackers-part-number-66/FDA-Z-1734-2026
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