Z-0629-2018 Class II Terminated
FDA device recall Z-0629-2018 was initiated by Cincinnati Sub-Zero Products LLC on November 27, 2017 and is designated Class II. Reason for recall: 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 & disinfect… The recall status is terminated (terminated July 2, 2018). Affected quantity: 1355 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- November 27, 2017
- Termination Date
- July 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1355 units
Product 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 for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
none