FDA Enforcement
Class II
Terminated
Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
Recall: Z-0629-2018
·
Reported February 21, 2018
Enforcement
- Recall Number
- Z-0629-2018
- Event ID
- 78173
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cincinnati Sub-Zero Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 21, 2018
- Initiation Date
- November 27, 2017
- Classification Date
- February 15, 2018
- Termination Date
- July 2, 2018
- Address
- 12011 Mosteller Rd, Cincinnati, OH, 45241-1528, United States
Description
Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
Reason
Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
Code Info
none
Distribution
US Nationwide Distribution
Quantity
1355 units