Cincinnati, OH, United States
Cincinnati Sub-Zero Products LLC recalls
1 recall recorded since 2018, most recently on 27 November 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 27 November 2017
- Terminated
- 2 July 2018
- 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.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0629-2018
- 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 conjunct
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.