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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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Critical RiskFDA Device
Medical Devices/Home Healthcare

Ventec Life Systems, Inc.: VOCSN Patient Breathing Packages Recalled Due to Detachment and Leaking Risk

Agency Publication Date: February 23, 2024
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Summary

Ventec Life Systems is recalling approximately 250 VOCSN Patient Breathing Packages (Pediatric, Active, Oxygen, Blue) because the bonded spiral wrap may detach before or during ventilation. This manufacturing defect can cause the breathing circuit to leak or become blocked, compromising the delivery of air to patients who rely on mechanical ventilation. These circuits were used with the VOCSN Unified Respiratory System and were distributed in several U.S. states and Japan.

Risk

The detachment of the spiral wrap can lead to sudden air leaks or blockages in the breathing circuit, which may prevent the patient from receiving necessary oxygen or ventilation. For ventilator-dependent patients, this failure could result in serious respiratory injury or death.

What You Should Do

  1. Identify your product by checking the packaging labels for Part Number PRT-01013-000 (Box Label), Part Number PRT-00802-001 (Pouch Label), or UDI-DI Code 00855573007594.
  2. Check your specific production codes to see if they match Lot Number 220922 or Pack Slip Lot Number 257337.
  3. If you have an affected breathing circuit, contact your healthcare provider or Ventec Life Systems immediately to determine if it is safe to continue use or if a replacement is required.
  4. Report any device failures or injuries to the manufacturer and your medical team.
  5. Contact Ventec Life Systems for further instructions regarding potential replacements or refunds related to this manufacturing issue.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider consultation

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

Affected Products

Product: VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue)
Model / REF:
PRT-01013-000
PRT-00802-001
UPC Codes:
00855573007594
Lot Numbers:
220922
257337

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93806
Status: Active
Manufacturer: Ventec Life Systems, Inc.
Sold By: Medical device distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 250 breathing circuits
Distributed To: California, Colorado, Florida, Hawaii, Indiana, Missouri, North Carolina, Washington

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.