Accueil/Tous les Rappels/FDA-Z-2305-2026
FDA DevicesClass II

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

Publié le: 10 juin 2026ID du rappel: Z-2305-2026Catégorie: Dispositifs MédicauxPays: États-Unis
US
Medical DeviceFDA DevicesUSUS

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

Recalling Firm: DeRoyal Industries Inc

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Traduire l’alerteTranslate notice text, hazard warnings, and descriptions into any supported language.

Motif du rappel / Danger

Sterile wound dressing, lacks sterility assurance

Description du produit & Identification

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

Produits concernés

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

Additional Source Details

FieldValue
CityPowell
StateTN
Event id99044
Address 1200 Debusk Ln
Code infoLot: 63295141/UDI: None
Postal code37849-4703
Report date20260610
Product typeDevices
Product quantity800 units
Reason for recallSterile wound dressing, lacks sterility assurance
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260518
Center classification date20260603

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 DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)?

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 responsableDeRoyal Industries Inc
  • StatusOngoing
  • Niveau de risqueClass II
  • DistributionUS Nationwide distribution in the states of FL & NC.
Recall Hazard Severity
High Alert (Class I)
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🚨 SAFETY ALERT: DeRoyal Industries Inc - DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

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https://therecallfile.com/fr/recalls/deroyal-industries-inc-ref-46-406-covaderm-plus-vascular-access-dressi/FDA-Z-2305-2026
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