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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

Sorin Group USA, Inc.: Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.

Agency Publication Date: July 15, 2015
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Affected Products

Product: Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.

Product code 16-02-80 Serial number 16S10027-16S15641

Lot Numbers:
16-02-80
Product: Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Product code 16-02-81 Serial number 16S10743-16S11708

Lot Numbers:
16-02-81
Product: Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Product code 16-02-82 Serial number 16S10772-16S15523

Lot Numbers:
16-02-82
Product: Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Product code 16-02-83 Serial number 16S11455-16S15190

Lot Numbers:
16-02-83
Product: Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Product code 16-02-85 Serial number 16S10958-16S15634

Lot Numbers:
16-02-85
Product: Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

Product code 16-02-95 Serial number 16S12004-16S15385

Lot Numbers:
16-02-95

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71593
Status: Resolved
Manufacturer: Sorin Group USA, Inc.
Manufactured In: United States
Units Affected: 6 products (2837; 21; 283; 28; 1755; 131)

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.

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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.