Z-2140-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 4, 2021
- Initiation Date
- July 14, 2021
- Termination Date
- August 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33
Product Description
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
Reason for Recall
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
Distribution Pattern
Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
Code Information
HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.