Devices

Device Recall Hudson RCI AQUA Flex, Hygroscopic Condenser Humidifier

Model / Serial
Catalog number-- 1570, Lot numbers: 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948 and 200951.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution in the states of CA, FL, GA, KY, KS, IL, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI and to the country of Japan.
Product Description
Hudson RCI¿ AQUA+¿ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air.
Manufacturer
Teleflex Medical
1 Event
- Recall of Device Recall Hudson RCI AQUA Flex, Hygroscopic Condenser Humidifier

Manufacturer

Teleflex Medical

Manufacturer Address
Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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