Startseite/Alle Rückrufe/FDA-Z-2797-2026
FDA DevicesClass I

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

Veröffentlicht: 12. August 2026Rückruf-ID: Z-2797-2026Kategorie: MedizinprodukteLand: Vereinigte Staaten
US
Medical DeviceFDA DevicesUSUS

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

Recalling Firm: AVID Medical, Inc.

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Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Produktbeschreibung & Identifikation

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

Betroffene Produkte

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

Additional Source Details

FieldValue
CityToano
StateVA
Event id99339
Address 19000 Westmont Dr
Code infoUDI-DI 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932
Postal code23168-9351
Report date20260812
Product typeDevices
Product quantity5168 kits
Reason for recallAffected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260430
Initial firm notificationTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date20260731

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 Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY...?

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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Übersicht

  • Rückrufendes UnternehmenAVID Medical, Inc.
  • StatusOngoing
  • RisikostufeClass I
  • DistributionUS Nationwide distribution in the states of NC and TX.
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

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🚨 SAFETY ALERT: AVID Medical, Inc. - Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

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