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Maquet Medical Systems USA Recall 88285

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.

Maquet Medical Systems USA Recall 88285 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2140-2021
Event ID88285
Event DescriptionHeater 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.
Product TypeDevices
DistributionDistribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
Quantity33
Recall ReasonThere 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.
Device Classification20210804
Device Code InfoHCU 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.
Center Classification Date20210723
Recall Initiation Date20210714
Recalling FirmMaquet Medical Systems USA
Initial Notification Letter
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