The Recall Desk

FDA (Devices) recall action 90757

Fresenius Medical Care Holdings, Inc. recalled 2 products on 2022-09-28

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-09-28
Critical
0
Units
30

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2022-09-28

    Hemodialysis Water Purification Unit Recalled for Missing EMI Shielding

    Fresenius is recalling 24 units of the AquaC UNO H reverse osmosis unit because internal ethernet cables lack ferrite cores, compromising electromagnetic compatibility in hemodialysis water purification systems.

    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
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2022-09-28

    Dialysis water-treatment unit recalled for missing ferrite cores in cables

    Fresenius is recalling 6 units of the AquaC UNO H reverse osmosis unit used with hemodialysis systems due to missing ferrite cores in internal ethernet cables affecting electromagnetic compatibility.

    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
    Category
    Distribution
    11 states