Accueil/Tous les Rappels/FDA-Z-1778-2026
FDA DevicesClass II

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Publié le: 15 avril 2026ID du rappel: Z-1778-2026Catégorie: Dispositifs MédicauxPays: États-Unis
US
Medical DeviceFDA DevicesUSUS

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Recalling Firm: Cook Incorporated

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Motif du rappel / Danger

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Description du produit & Identification

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Produits concernés

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Additional Source Details

FieldValue
CityBloomington
StateIN
Event id98495
Address 1750 N Daniels Way
Code infoReference Part Number APMY-2.5-15-0-2.5, UDI (01)00827002584129(17)270212(10)15894185X, Lot Number 15894185X; Reference Part Number APMY-2.5-15-0-2.5, UDI (01)00827002584129(17)261108(10)15747314X, Lot Number 15747314X; Reference Part Number APMY-4.0-21J-1-12, UDI (01)00827002584198(17)260202(10)15264260X, Lot Number 15264260X;
Postal code47404-9120
Report date20260415
Product typeDevices
Product quantity20 units
Reason for recallProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260305
Initial firm notificationTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date20260406

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 COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Refere...?

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 responsableCook Incorporated
  • StatusOngoing
  • Niveau de risqueClass II
  • DistributionWorldwide distribution.
Recall Hazard Severity
High Alert (Class I)
Alerte officielle de l’agence

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🚨 SAFETY ALERT: Cook Incorporated - COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

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https://therecallfile.com/fr/recalls/cook-medical-arterial-pressure-monitoring-tray-reference-part-number-a/FDA-Z-1778-2026
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