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Medium RiskFDA Device
Medical Devices

Quest Medical, Inc.: Q2 Multiport Extension Sets Recalled for Device Defect

Agency Publication Date: October 28, 2023
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Summary

Quest Medical, Inc. has recalled approximately 17,700 Q2 Multiport Extension sets (REF: 9520). These sterile, single-use devices are used to deliver intravenous (IV) fluids and medications to patients through needles-free components and manifolds. The recall was initiated because the devices may not function as intended during the administration of fluids via gravity, syringe, or infusion pump. Consumers should contact their healthcare provider or the manufacturer to determine if their specific units are affected and to receive further instructions.

Risk

If the extension set fails during use, it could lead to the improper delivery of critical intravenous fluids or medications, potentially resulting in under-dosing or over-dosing of treatments. No specific injuries have been reported in the provided data, but device failure in a clinical setting poses a moderate risk to patient safety.

What You Should Do

  1. Identify if you have the Q2 Multiport Extension set by checking the packaging for Reference Number (REF) 9520 and UDI (01)20634624952007.
  2. Check the lot numbers on your device packaging against the following affected lots: 69083, 69136, 69329, 69330, 69396, 69397, 69471, and 69472.
  3. If your device matches one of the affected lot numbers, contact your healthcare provider or Quest Medical, Inc. immediately for further instructions and information regarding a potential refund.
  4. Healthcare facilities should isolate any remaining inventory of the affected lots to ensure they are not used for patient care.
  5. Contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer contact and healthcare provider consultation

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

Affected Products

Product: Q2 Multiport Extension set, REF: 9520
Model / REF:
REF: 9520
UDI: (01)20634624952007
Lot Numbers:
69083
69136
69329
69330
69396
69397
69471
69472

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93116
Status: Active
Manufacturer: Quest Medical, Inc.
Sold By: Hospitals; Medical clinics
Manufactured In: United States
Units Affected: 17,700 units
Distributed To: Texas, Utah, Florida, California, Virginia, Colorado, Alabama, Nevada, Illinois, Oklahoma, Ohio, Pennsylvania, Missouri, Minnesota, Montana, Washington, Michigan, Tennessee, New York

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.