FDA recall Z-2092-2021

Product

Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures

Reason for recall

There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.

Distribution

Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turkey, UAE

Key facts

Status

Terminated

Initiation date

2021-06-17

Report date

2021-07-28

Termination date

2023-03-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Blue Ash, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2092-2021