Recall Z-1498-2020— LivaNova USA Inc.
Class II · Terminated
Class II FDA medical device recall by LivaNova USA Inc., initiated 2020-02-24, terminated 2022-08-04. It names one FDA 510(k) clearance: K052601. Product: 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: The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination..
- Recalling firm
- LivaNova USA Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-24
- Terminated
- 2022-08-04
- Firm location
- Arvada, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.