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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

Smiths Medical ASD Inc.: Portex Bivona Pediatric Tracheostomy Tubes Recalled for Labeling Error

Agency Publication Date: October 31, 2023
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Summary

Smiths Medical ASD Inc. has recalled Portex Bivona Pediatric Tracheostomy Tubes (Cuffless, Model 60P045) because the outer unit boxes were printed with an incorrect expiration date. The boxes incorrectly list the manufacturing date of March 17, 2021, as the expiration date, while the individual sterile packaging inside correctly shows an expiration date of March 17, 2026. This recall affects Lot #4125816, which includes sterile devices distributed across several states and Canada.

Risk

Although the devices themselves are not expired or defective, the incorrect date on the outer box could lead to confusion or the unnecessary disposal of usable medical equipment. If users rely on the incorrect date, it could cause a delay in medical procedures or patient care.

What You Should Do

  1. Check your inventory for Portex Bivona Pediatric Tracheostomy Tubes, Cuffless, Model 60P045.
  2. Identify affected products by looking for Lot #4125816 and UDI-DI 15021312005769 on the packaging.
  3. Inspect the expiration date on the outer box; if it reads '3/17/2021', cross-reference it with the individual sterile packaging inside, which should correctly read '3/17/2026'.
  4. Contact Smiths Medical ASD Inc. at their Minneapolis office or through your medical supplier to receive guidance on labeling corrections or replacement units.
  5. If you have questions about the safety or use of the device, contact your healthcare provider for further instructions.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

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

Affected Products

Product: Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile
Model / REF:
60P045
UPC Codes:
15021312005769
Lot Numbers:
4125816 (Exp. 3/17/2026)
Date Ranges: 3/17/2021 (Incorrectly labeled box expiration), 3/17/2026 (Correct internal packaging expiration)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92996
Status: Active
Manufacturer: Smiths Medical ASD Inc.
Sold By: medical supply distributors
Manufactured In: United States
Distributed To: Arizona, California, Florida, Hawaii, Illinois, Indiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, Texas, Virginia, 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.