LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Reported: March 25, 2020 Initiated: February 24, 2020 #Z-1498-2020
Product Description
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Reason for Recall
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Details
- Recalling Firm
- LivaNova USA Inc.
- Units Affected
- Total Worldwide=9309 systems (2713 system in U.S.)
- Distribution
- U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none
- Location
- Arvada, CO
Frequently Asked Questions
What product was recalled? ▼
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.. Recalled by LivaNova USA Inc.. Units affected: Total Worldwide=9309 systems (2713 system in U.S.).
Why was this product recalled? ▼
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1498-2020.
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