Fresenius Medical Care Holdings, Inc.: 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 Nu

Is my product affected?

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

• UPC 4251285200234

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

What happened

Fresenius Medical Care is recalling the AquaC UNO H reverse osmosis unit (Part Number 24-10VA-1) used with hemodialysis systems. The internal ethernet cables in these units are missing one or both ferrite cores, which means the device's electromagnetic compatibility cannot be guaranteed. A total of 24 units were distributed nationwide across Arizona, California, the District of Columbia, Florida, Georgia, Indiana, Massachusetts, Nevada, New York, Pennsylvania, and Texas.

The affected units can be identified by specific lot and serial numbers listed in the recall notice. The recall record does not specify a remedy or corrective action for consumers to take.

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: 24 units Lot/code info: UDI: (01)4251285200234(11)210628(21)1CHS5379 (01)4251285200234(11)160927(21)6CHS1270 (01)4251285200234(11)161109(21)6CHS1394 (01)4251285200234(11)161109(21)6CHS1435 (01)4251285200234(11)170131(21)7CHS1569 (01)4251285200234(11)170201(21)7CHS1583 (01)4251285200234(11)170213(21)7CHS1619 (01)4251285200234(11)170314(21)7CHS1641 (01)4251285200234(11)170519(21)7CHS1790 (01)4251285200234(11)170807(21)7CHS1953 (01)4251285200234(11)180326(21)8CHS2197 (01)4251285200234(11)181010(21)8CHS2608 (01)4251285200234(11)181102(21)8CHS2633 (01)4251285200234(11)181107(21)8CHS2644 Serial Numbers: 1CHS5379 6CHS1192 6CHS1194 6CHS1195 6CHS1196 6CHS1197 6CHS1198 6CHS1199 6CHS1200 6CHS1201 6CHS1233 6CHS1270 6CHS1394 6CHS1435 7CHS1569 7CHS1583 7CHS1619 7CHS1641 7CHS1790 7CHS1953 8CHS2197 8CHS2608 8CHS2633 8CHS2644

Source

Official record: FDA (Device enforcement) ↗

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

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