Olympus Corporation of the Americas: Paparrela-Type Vent Tube Recalled for Missing Expiration Date on Packaging

Agency Publication Date: February 7, 2024

Summary

Olympus is recalling 600 units of the Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM (Model 240044) used to ventilate the middle ear after ear infections. The recall was initiated because the expiration date is missing from the primary inner packaging, though it is correctly labeled on the outer box. While the product inside is sterile and safe to use until February 12, 2033, the missing label could lead to confusion regarding the device's shelf life.

Risk

If the outer box is discarded, healthcare providers may not know when the sterile tube expires. Using a medical device past its expiration date could potentially compromise its sterility, leading to a risk of infection in the middle ear.

What You Should Do

Identify your product by checking for the Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Model number 240044.
Check the packaging for Lot Number SM280573 and UDI 00821925031913.
Verify if the primary inner packaging is missing an expiration date; note that the correct expiration date for this specific lot is February 12, 2033.
Contact your healthcare provider or Olympus Corporation of the Americas at 1-800-848-9024 for further instructions regarding the affected units.
If you are a healthcare provider, ensure the outer box label is retained or the expiration date is noted before the inner packaging is separated from the secondary box.
For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification

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

Affected Products

Product: Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile

Model / REF:

240044

UPC Codes:

00821925031913

Lot Numbers:

SM280573

Date Ranges: February 12, 2033 (Expiration Date)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93785

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Medical distributors; Hospitals

Manufactured In: United States

Units Affected: 600 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 · 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.

Summary

What You Should Do

Identify your product by checking for the Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Model number 240044.

Check the packaging for Lot Number SM280573 and UDI 00821925031913.

Verify if the primary inner packaging is missing an expiration date; note that the correct expiration date for this specific lot is February 12, 2033.

Contact your healthcare provider or Olympus Corporation of the Americas at 1-800-848-9024 for further instructions regarding the affected units.

If you are a healthcare provider, ensure the outer box label is retained or the expiration date is noted before the inner packaging is separated from the secondary box.

For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.