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FDA (Device enforcement)Recalled 2022-06-16class ii

Fresenius Medical Care Holdings, Inc.: AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

Is my product affected?

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

  • UPC 04251285200234

Check against the official notice below — it lists the full affected range.

What happened

Fresenius Medical Care is recalling 318 units of the AquaC UNO H [120V, 60Hz, 1000VA] water treatment device distributed nationwide in the United States. An internal ethernet cable may be misaligned, causing its insulation to break down at high temperatures. This could allow electrical current to conduct through the ethernet cable to the ethernet port on the outside of the device.

If a service technician or authorized operator touches or manipulates the ethernet port while the device is powered, they face a risk of electrical shock. The recall affects devices with specific lot codes identified by their UDI-DI numbers, which span manufacturing dates from October 2018 through March 2022. The source document does not specify what an affected consumer should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

Details from the source

Reason for recall: Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock Distribution: US Nationwide distribution. Quantity: 318 units Lot/code info: UDI-DI: (01)04251285200234(11)220308(21)2CHS5788 (01)04251285200234(11)220308(21)2CHS5790 (01)04251285200234(11)220308(21)2CHS5791 (01)04251285200234(11)220309(21)2CHS5793 (01)04251285200234(11)210628(21)1CHS5379 (01)04251285200234(11)181107(21)8CHS2658 (01)04251285200234(11)181113(21)8CHS2659 (01)04251285200234(11)181121(21)8CHS2672 (01)04251285200234(11)181126(21)8CHS2673 (01)04251285200234(11)181126(21)8CHS2678 (01)04251285200234(11)181121(21)8CHS2683 (01)04251285200234(11)181126(21)8CHS2653 (01)04251285200234(11)181018(21)8CHS2629 (01)04251285200234(11)181029(21)8CHS2637 (01)04251285200234(11)181121(21)8CHS2652 (01)04251285200234(11)181106(21)8CHS2655 (01)04251285200234(11)181113(21)8CHS2660 (01)04251285200234(11)181121(21)8CHS2662 (01)04251285200234(11)181108(21)8CHS2663 (01)04251285200234(11)181112(21)8CHS2668 (01)04251285200234(11)181116(21)8CHS2669 (01)04251285200234(11)181120(21)8CHS2677 (01)04251285200234(11)181116(21)8CHS2679 (01)04251285200234(11)181105(21)8CHS2597 (01)04251285200234(11)181108(21)8CHS2601 (01)04251285200234(11)181102(21)8CHS2642 (01)04251285200234(11)181107(21)8CHS2645 (01)04251285200234(11)181108(21)8CHS2646 (01)04251285200234(11)181108(21)8CHS2648 (01)04251285200234(11)181109(21)8CHS2649 (01)04251285200234(11)181107(21)8CHS2654 (01)04251285200234(11)181107(21)8CHS2657 (01)04251285200234(11)181113(21)8CHS2666 (01)04251285200234(11)181112(21)8CHS2667 (01)04251285200234(11)181113(21)8CHS2671 (01)04251285200234(11)181107(21)8CHS2644 (01)042512852002

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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