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FDA (Device enforcement)Recalled 2022-06-21class ii

Fresenius Medical Care Holdings, Inc.: 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 Num

Is my product affected?

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

  • UPC 4251285200234

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

What happened

Fresenius Medical Care is recalling 6 units of the AquaC UNO H reverse osmosis unit (Fresenius Part Number 24-0970-1), a device used with hemodialysis systems. The recall affects units distributed nationwide in Arizona, California, the District of Columbia, Florida, Georgia, Indiana, Massachusetts, Nevada, New York, Pennsylvania, and Texas. The devices are being recalled because internal ethernet cables are missing one or both ferrite cores, which means the electromagnetic compatibility of the device cannot be ensured.

The specific serial numbers involved in this recall are 0CHS3987, 0CHS4108, 1CHS5372, 1CHS5405, 9CHS2881, and 9CHS3090. The source document does not specify what actions affected consumers should take in response to this recall.

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

Hazard

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

Details from the source

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. Quantity: 6 units Lot/code info: UDI: (01)4251285200234(11)200422(21)0CHS3987 (01)4251285200234(11)200526(21)0CHS4108 (01)4251285200234(11)210623(21)1CHS5372 (01)4251285200234(11)210707(21)1CHS5405 (01)4251285200234(11)190305(21)9CHS2881 (01)4251285200234(11)190529(21)9CHS3090 Serial Numbers: 0CHS3987 0CHS4108 1CHS5372 1CHS5405 9CHS2881 9CHS3090

Source

Official record: FDA (Device enforcement) ↗

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

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