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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

Atrium Medical Corporation: Atrium Oasis Drain Recalled for Incorrect Expiration Date

Agency Publication Date: December 28, 2023
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Summary

Atrium Medical Corporation is recalling 835 cases of the Atrium Oasis Drain Single W / AC (Part No. 3600-100) because a manufacturing error caused the devices to age faster than expected. This sterilization issue means the expiration date printed on the packaging is incorrect, as the product is actually expiring 48.3 days earlier than labeled. These medical devices were inadvertently distributed nationwide despite the nonconformance. Consumers and healthcare providers should check their inventory for affected lot numbers and contact the manufacturer or their healthcare provider for further guidance.

Risk

Using these medical drains after their actual, shortened expiration date of November 17, 2025, increases the risk of device failure or infection for both patients and healthcare providers due to the premature aging of the product.

What You Should Do

  1. Check your medical inventory for the Atrium Oasis Drain Single W / AC, Part Number 3600-100.
  2. Verify if your product matches UDI-DI 00650862110012 with Lot Numbers 492065 or 492075.
  3. Be aware that the expiration date on the label is inaccurate; the product should not be used after the shortened expiration date of November 17, 2025.
  4. Contact your healthcare provider or Atrium Medical Corporation at their Merrimack, NH location (40 Continental Blvd) for specific instructions regarding product replacement or return.
  5. For further information or to report concerns, 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

Product notification and instructions for nonconforming units

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

Affected Products

Product: Atrium Oasis Drain Single W / AC (6 units/case)
Model / REF:
3600-100
Lot Numbers:
492065
492075
Date Ranges: November 17, 2025 (Shortened Expiration Date)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93553
Status: Active
Manufacturer: Atrium Medical Corporation
Sold By: authorized medical distributors
Manufactured In: United States
Units Affected: 835 cases total (6 units/case)
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.