FDA DevicesClass II

American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM

Publicado: 2 de septiembre de 2026ID de Retiro: Z-3000-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM

Recalling Firm: American Contract Systems Inc

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Motivo del Retiro / Peligro

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

Descripción del Producto e Identificación

American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM

Additional Source Details

FieldValue
CityTiffin
StateOH
Event id99514
Address 185 Shaffer Park Dr
Address 2N/A
Code infoLot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026
Postal code44883-9290
Report date20260902
Product typeDevices
Product quantity30 units
Reason for recallThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260629
Initial firm notificationLetter
Center classification date20260821

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 American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM?

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 ResponsableAmerican Contract Systems Inc
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionUS Nationwide distribution in the states of IA, OH.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: American Contract Systems Inc - American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM

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https://therecallfile.com/es/recalls/american-contract-system-convenience-kit-cv-b-pack-model-catalog-numbe/FDA-Z-3000-2026
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