FDAJuly 14, 2021device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
maquet medical systemsmaquetmaquet medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDANicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.2026-05-14
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
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- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
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