FDA recall Z-1769-2022

Fresenius Medical Care Holdings, Inc. · Class II · device

Product

AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US

Reason for recall

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

Distribution

US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.

Key facts

Status: Ongoing
Initiation date: 2022-06-21
Report date: 2022-09-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1769-2022