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Open, Classified

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

FDA Recall Z-1770-2022 · Posted 2022-09-19

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusOpen, Classified
Product CodeFIP
Date Initiated2022-06-21
Product Quantity6 units

Reason for Recall

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

Firm Action

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) issued Urgent Medical Deice Correction letter (FA-2022-20-C) on 06/21/22 via First Class Mail. Letter states reason for recall, health risk and action to take: A Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) Water Systems Service Specialist will be contacting you to schedule a correction of your portable Water Treatment system. Only a Certified AquaC UNO H System Technician or FMCRTG Water Systems Service Specialist may perform this service. If choosing to correct via your own Certified AquaC UNO H System Technician, you will need to contact FMCRTG prior to performing the correction. FMCRTG will provide the necessary instruction via a Change Notification. For questions or concerns, please contact FMCRTG Technical Support Services at 888-553-1109.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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