Product Wiki · Recalls · U.S. FDA — Device Enforcement

Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies… — recall Z-0348-2017

U.S. FDA — Device Enforcement · United States · 2016-09-27 · Class II

As described by U.S. FDA — Device Enforcement: Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water th

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0348-2017
Date of alert
2016-09-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Maquet Cardiovascular Us Sales, Llc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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