FDA recall Z-1498-2020

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 for recall

The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.

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

Key facts

Status

Terminated

Initiation date

2020-02-24

Report date

2020-03-25

Termination date

2022-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arvada, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1498-2020