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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

CardioQuip, LLC: Modular Cooler-Heaters Recalled for Potential Bacterial Contamination

Agency Publication Date: December 15, 2023
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Summary

CardioQuip, LLC is recalling six units of its Modular Cooler-Heater (Models MCH-1000(i) and MCH-1000(m)) because the devices may contain bacterial contamination. These devices are used during medical procedures to regulate a patient's temperature, and contamination within the system can lead to serious patient infections. This voluntary recall affects specific lots of these 115V-60Hz units manufactured in the United States.

Risk

The water used in these cooler-heater units can become contaminated with bacteria, which may be aerosolized and transmitted to a patient during surgery, potentially causing severe or life-threatening infections.

What You Should Do

  1. Identify your device by checking the model and lot numbers on the unit's identification plate. Affected Model MCH-1000(i) units include lot numbers 10161316, 10161479, 10160241, and 10161040 (UDI 00860000846103).
  2. Check Model MCH-1000(m) units for lot numbers 11160294 and 11161110 (UDI 00860000846110).
  3. If you identify an affected unit, contact CardioQuip, LLC directly at their College Station, Texas facility for specific guidance on remediation and to discuss any necessary inspections.
  4. Healthcare providers should monitor patients who have undergone procedures involving these specific units for any signs of post-operative infection.
  5. Contact your healthcare provider or CardioQuip, LLC for further instructions and potential refund or repair information.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instruction

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

Affected Products

Product: CardioQuip Modular Cooler-Heater, Model: MCH-1000(i)
Model / REF:
MCH-1000(i)
UPC Codes:
00860000846103
Lot Numbers:
10161316
10161479
10160241
10161040
Product: CardioQuip Modular Cooler-Heater, Model: MCH-1000(m)
Model / REF:
MCH-1000(m)
UPC Codes:
00860000846110
Lot Numbers:
11160294
11161110

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93446
Status: Active
Manufacturer: CardioQuip, LLC
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 2 products (4 units; 2 units)
Distributed To: California, Texas, Pennsylvania, Washington, Ohio, Nebraska

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.