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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Sarnova HC, Llc: Nasal Intubation Kits Recalled for Incompatible Tube Holders

Agency Publication Date: March 19, 2024
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Summary

Sarnova HC, Llc has recalled approximately 1,090 Curaplex Nasal Intubation Kits because the included endotracheal tube holder is not compatible with nasal intubation procedures. This defect means that in an emergency medical situation, practitioners may be unable to properly secure the breathing tube once it is inserted. These kits were distributed nationwide across the United States and were designed for emergency airway management.

Risk

The incompatible tube holder prevents medical staff from securing the endotracheal tube after a nasal intubation, which could lead to the tube becoming displaced or failing to provide a stable airway during a life-threatening emergency. No injuries have been reported to date.

What You Should Do

  1. Check your inventory for Curaplex Nasal Intubation Kits with 6mm Endotrol Tubes (Item 023060S) featuring UDI/GTIN 00815277020008 (each) or 00810071639630 (case) and Lot Numbers ASM0038077, ASM0038129, ASM0038334, or ASM0038598.
  2. Check your inventory for Curaplex Nasal Intubation Kits with 7mm Endotracheal Tubes (Item 023070S) featuring UDI/GTIN 00815277020015 (each) or 00810071639647 (case) and Lot Numbers ASM0038078, ASM0038130, ASM0038284, or ASM0038395.
  3. Immediately stop using any kits identified with the affected lot numbers and quarantine them to prevent use in medical procedures.
  4. Contact your healthcare provider or Sarnova HC, Llc directly at 1-800-533-0523 for further instructions regarding the return or replacement of these kits.
  5. For additional information, you may contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Curaplex Nasal Intubation Kit with 6mm Endotrol Tube
Model / REF:
023060S
UPC Codes:
00815277020008
00810071639630
Lot Numbers:
ASM0038077
ASM0038129
ASM0038334
ASM0038598
Product: Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube
Model / REF:
023070S
UPC Codes:
00815277020015
00810071639647
Lot Numbers:
ASM0038078
ASM0038130
ASM0038284
ASM0038395

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94116
Status: Active
Manufacturer: Sarnova HC, Llc
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 2 products (540 kits; 550 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.