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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: Thoracic Catheters Recalled for Inaccurate Expiration Dates

Agency Publication Date: December 2, 2023
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Summary

Atrium Medical Corporation has recalled approximately 2,460 units of the Atrium Firm PVC Thoracic Catheter (36FR Straight, part number 15036). A sterilization issue caused these catheters to age faster than intended, which means the expiration date printed on the packaging is incorrect and cannot be relied upon. The catheters were distributed to healthcare facilities in 14 states, including California, Florida, Illinois, and Texas. Consumers and healthcare providers should contact the manufacturer or their healthcare facility regarding affected stock.

Risk

The premature aging of the device may compromise the catheter's physical integrity or its sterile packaging. Using an aged or non-sterile catheter can lead to serious health complications, such as infections or device failure during medical procedures.

What You Should Do

  1. Check your medical supplies for Atrium Firm PVC Thoracic Catheter 36FR Straight (part number 15036) with lot number ME234686 and UDI-DI 00650862150360.
  2. Verify if the package displays an expiration date of 2023-02-24, as these specific units are affected by the sterilization nonconformance.
  3. Immediately stop using any affected catheters and secure them in a safe location to prevent further use.
  4. Contact Atrium Medical Corporation or your healthcare provider to receive instructions on returning the product and to discuss potential replacements or refunds.
  5. If you have concerns about a medical procedure involving these devices, contact your healthcare provider for guidance.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer.

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

Affected Products

Product: Atrium Firm PVC Thoracic Catheter 36FR Straight
Model / REF:
15036
UPC Codes:
00650862150360
Lot Numbers:
ME234686 (Exp 2023-02-24)
Date Ranges: Expiration date 2023-02-24

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93408
Status: Active
Manufacturer: Atrium Medical Corporation
Sold By: Healthcare facilities; Medical supply distributors
Manufactured In: United States
Units Affected: 2460 units (246 cases, 10 units/case)
Distributed To: Alabama, Arizona, California, Florida, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, New Jersey, Pennsylvania, Tennessee, Texas

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.