LivaNova Heater-Cooler System 3T - Product Usage: The recall: Contamination
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…
Why was LivaNova Heater-Cooler System 3T - Product Usage: The recalled?
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device Listing: E572259 Product Code Product Description Affected Serial Number range 16-02-80 Heater-Cooler 3T, 230V 16S10027 16S16874 16-02-81 Heater-Cooler 3T, 240V 16S10743 16S11708 16-02-82 Heater-Cooler 3T, 208V 16S10772 16S16840 16-02-83 Heater-Cooler 3T, 127V 16S11455 16S16509 16-02-85 Heater-Cooler 3T, 120V 16S10958 16S16847 16-02-95 Heater-Cooler 3T, 200V 16S12004 16S16818
- 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…
- Recalling firm
- LivaNova USA Inc.
- Quantity
- 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
- Recall date
- March 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)