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.
Reported: August 4, 2021 Initiated: July 14, 2021 #Z-2140-2021
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.
Details
- Recalling Firm
- Maquet Medical Systems USA
- Units Affected
- 33
- Distribution
- Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Maquet Medical Systems USA. Units affected: 33.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 4, 2021. Severity: Moderate. Recall number: Z-2140-2021.
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