Recall Z-0629-2018— Cincinnati Sub-Zero Products LLC
Class II · Terminated
Class II FDA medical device recall by Cincinnati Sub-Zero Products LLC, initiated 2017-11-27, terminated 2018-07-02. It names one FDA 510(k) clearance: K122813. Product: 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..
- Recalling firm
- Cincinnati Sub-Zero Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-27
- Terminated
- 2018-07-02
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.