FDAFDA · Food and drugs·Recall number Z-1463-2022
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Published August 3, 2022 · Recall initiated: June 16, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- 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)04251285200234(11)200902(21)0CHS4640 (01)04251285200234(11)200609(21)0CHS4197 (01)04251285200234(11)200523(21)0CHS4078 (01)04251285200234(11)200522(21)0CHS4077 (01)04251285200234(11)200526(21)0CHS4108 (01)04251285200234(11)200428(21)0CHS3976 (01)04251285200234(11)200422(21)0CHS3987 (01)04251285200234(11)200423(21)0CHS3977 (01)04251285200234(11)200422(21)0CHS3986 (01)04251285200234(11)191204(21)9CHS3600 (01)04251285200234(11)190529(21)9CHS3090 (01)04251285200234(11)190311(21)9CHS2916 (01)04251285200234(11)190306(21)9CHS2891 (01)04251285200234(11)190305(21)9CHS2881 (01)04251285200234(11)190215(21)9CHS2819 (01)04251285200234(11)190215(21)9CHS2820 (01)04251285200234(11)220208(21)2CHS5780 (01)04251285200234(11)220121(21)2CHS5763 (01)04251285200234(11)220126(21)2CHS5764 (01)04251285200234(11)220127(21)2CHS5765 (01)04251285200234(11)220203(21)2CHS5766 (01)04251285200234(11)220203(21)2CHS5767 (01)04251285200234(11)210928(21)1CHS5583 (01)04251285200234(11)210928(21)1CHS5584 (01)04251285200234(11)210928(21)1CHS5585 (01)04251285200234(11)210928(21)1CHS5586 (01)04251285200234(11)210930(21)1CHS5596 (01)04251285200234(11)210930(21)1CHS5597 (01)04251285200234(11)211004(21)1CHS5598 (01)04251285200234(11)210914(21)1CHS5555 (01)04251285200234(11)210915(21)1CHS5556 (01)04251285200234(11)210915(21)1CHS5557 (01)04251285200234(11)210909(21)1CHS5542 (01)04251285200234(11)210908(21)1CHS5545 (01)04251285200234(11)210908(21)1CHS5548 (01)04251285200234(11)210907(21)1CHS5539 (01)04251285200234(11)210920(21)1CHS5566 (01)04251285200234(11)210920(21)1CHS5567 (01)04251285200234(11)210921(21)1CHS5569 (01)04251285200234(11)210920(21)1CHS5570 (01)04251285200234(11)210929(21)1CHS5589 (01)04251285200234(11)210929(21)1CHS5590 (01)04251285200234(11)210929(21)1CHS5591 (01)04251285200234(11)210929(21)1CHS5593 (01)04251285200234(11)210930(21)1CHS5594 (01)04251285200234(11)210923(21)1CHS5575 (01)04251285200234(11)210924(21)1CHS5576 (01)04251285200234(11)210924(21)1CHS5578 (01)04251285200234(11)210927(21)1CHS5579 (01)04251285200234(11)210922(21)1CHS5587 (01)04251285200234(11)210922(21)1CHS5573 (01)04251285200234(11)210922(21)1CHS5574 (01)04251285200234(11)210927(21)1CHS5581 (01)04251285200234(11)210928(21)1CHS5582 (01)04251285200234(11)210916(21)1CHS5560 (01)04251285200234(11)210916(21)1CHS5562 (01)04251285200234(11)210917(21)1CHS5564 (01)04251285200234(11)210726(21)1CHS5465 (01)04251285200234(11)210721(21)1CHS5452 (01)04251285200234(11)210723(21)1CHS5455 (01)04251285200234(11)210503(21)1CHS5241 (01)04251285200
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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