RecallWatchUSA

Home / Recalls / Medical Devices

Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresen

Recalled September 28, 2022 · FDA recall Z-1770-2022 · Fresenius Medical Care Holdings

Hazard
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured · FDA Class II
Units
6 units
Sold at
US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.

Description

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

Product
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Fresenius Medical Care Holdings, Inc. recalls AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresen | RecallWatchUSA