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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: Curaplex Field Cric Kits Recalled for Tube Holder Incompatibility

Agency Publication Date: January 12, 2024
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Summary

Sarnova HC, Llc has recalled approximately 1,078 Curaplex Field Cric Kits and Curaplex Cricothyrotomy Field Kits because the included Endotracheal Tube Holder is not compatible with the intended procedure. This defect means that during an emergency airway procedure, medical practitioners may be unable to properly secure the breathing tube after it has been inserted. The recall affects kits with specific item numbers and lot numbers distributed nationwide. Users are advised to contact the manufacturer or their healthcare provider for guidance on how to handle the affected medical supplies.

Risk

Because the tube holder is incompatible, practitioners cannot properly secure the airway tube during a cricothyrotomy procedure. This creates a significant risk that the tube could become dislodged, potentially leaving a patient without a secure airway during a critical medical emergency.

What You Should Do

  1. Immediately check your medical supply inventory for Curaplex Field Cric Kit with ET Tube (Item Number 36611) with lot numbers ASM0037579, ASM0037631, ASM0037905, or ASM0038197.
  2. Check your inventory for Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm (Item Number 351631i-A) with lot numbers ASM0037685 or ASM0037887.
  3. Identify affected kits by locating the Item Number and Lot Number printed on the external kit packaging or labeling.
  4. If you possess any of the affected lots, contact Sarnova HC, Llc at 5000 Tuttle Crossing Blvd, Dublin, Ohio, 43016-1534 for specific instructions on how to return or remediate the kits.
  5. Consult with your healthcare provider or medical director regarding alternative means of securing endotracheal tubes if these kits have been deployed in the field.
  6. For further questions regarding this recall, 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

Contact manufacturer for further instructions

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

Affected Products

Product: Curaplex Field Cric Kit with ET Tube
Model / REF:
36611
Lot Numbers:
ASM0037579
ASM0037631
ASM0037905
ASM0038197
Product: Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm
Model / REF:
351631i-A
Lot Numbers:
ASM0037685
ASM0037887

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93665
Status: Active
Manufacturer: Sarnova HC, Llc
Sold By: Sarnova HC, Llc; Healthcare professionals
Manufactured In: United States
Units Affected: 2 products (1063 kits; 15 kits)
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.