FDA DevicesClass II

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Publicado: 4 de marzo de 2026ID de Retiro: Z-1468-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Recalling Firm: Medline Industries, LP

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Traducir AvisoTranslate notice text, hazard warnings, and descriptions into any supported language.

Motivo del Retiro / Peligro

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

Descripción del Producto e Identificación

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Productos Afectados

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Additional Source Details

FieldValue
CityNorthfield
StateIL
Event id98333
Address 13 Lakes Dr
Address 2N/A
Code infoUDI-DI (ea) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708
Postal code60093-2753
Report date20260304
Product typeDevices
Product quantity150
Reason for recallAffected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260108
Initial firm notificationLetter
Center classification date20260224

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 Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167?

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 ResponsableMedline Industries, LP
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionUS Nationwide distribution.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: Medline Industries, LP - Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

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https://therecallfile.com/es/recalls/convenience-kits-containing-tego-connectors-medline-dialysis-drsng-chn/FDA-Z-1468-2026
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