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

Fresenius Medical Care Holdings, Inc.: AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

Is my product affected?

AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

  • UPC 04251285200234

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

What happened

Fresenius Medical Care is recalling 277 units of the AquaC UNO H model (120V, 60Hz) distributed nationwide in the United States. The recalled devices contain an internal ethernet cable that may be misaligned, causing the cable's insulation to deteriorate due to high temperatures. This damage could allow the internal ethernet cable to conduct electrical current to the ethernet port on the outside of the device.

The hazard poses a risk of electrical shock to service technicians and other authorized operators who touch or manipulate the ethernet port. The recall affects specific lot codes identified by UDI-DI numbers dating from June 2020 through January 2022. The source document does not specify what actions affected consumers or device users should take 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: 277 units Lot/code info: UDI-DI: (01)04251285200234(11)220121(21)2CHS5762 (01)04251285200234(11)211018(21)1CHS5601 (01)04251285200234(11)211019(21)1CHS5602 (01)04251285200234(11)211019(21)1CHS5603 (01)04251285200234(11)211019(21)1CHS5604 (01)04251285200234(11)211018(21)1CHS5605 (01)04251285200234(11)211018(21)1CHS5606 (01)04251285200234(11)211004(21)1CHS5592 (01)04251285200234(11)211018(21)1CHS5595 (01)04251285200234(11)211004(21)1CHS5599 (01)04251285200234(11)211004(21)1CHS5600 (01)04251285200234(11)211018(21)1CHS5607 (01)04251285200234(11)210909(21)1CHS5543 (01)04251285200234(11)210914(21)1CHS5554 (01)04251285200234(11)210915(21)1CHS5558 (01)04251285200234(11)210909(21)1CHS5544 (01)04251285200234(11)210908(21)1CHS5546 (01)04251285200234(11)210908(21)1CHS5547 (01)04251285200234(11)210906(21)1CHS5536 (01)04251285200234(11)210906(21)1CHS5537 (01)04251285200234(11)210906(21)1CHS5538 (01)04251285200234(11)210907(21)1CHS5540 (01)04251285200234(11)210907(21)1CHS5541 (01)04251285200234(11)210920(21)1CHS5565 (01)04251285200234(11)210921(21)1CHS5568 (01)04251285200234(11)210929(21)1CHS5588 (01)04251285200234(11)210921(21)1CHS5572 (01)04251285200234(11)210927(21)1CHS5580 (01)04251285200234(11)210916(21)1CHS5559 (01)04251285200234(11)210916(21)1CHS5561 (01)04251285200234(11)210917(21)1CHS5563 (01)04251285200234(11)210707(21)1CHS5405 (01)04251285200234(11)210623(21)1CHS5372 (01)04251285200234(11)210329(21)1CHS5157 (01)04251285200234(11)200902(21)0CHS4639 (01)04251285200234(11)200902(21)0CHS4641 (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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