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U.S. Department of Health and Human Services

Class 2 Device Recall AquaC UNO H Water Purification System

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 Class 2 Device Recall AquaC UNO H Water Purification Systemsee related information
Date Initiated by FirmJune 16, 2022
Date PostedJuly 25, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1463-2022
Recall Event ID 90527
510(K)NumberK143617 
Product Classification Subsystem, water purification - Product Code FIP
ProductAquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Code Information 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)04251285200234(11)210503(21)1CHS5244 (01)04251285200234(11)210503(21)1CHS5246 (01)04251285200234(11)210428(21)1CHS5235 (01)04251285200234(11)210428(21)1CHS5239 (01)04251285200234(11)210414(21)1CHS5170 (01)04251285200234(11)210415(21)1CHS5173 (01)04251285200234(11)210330(21)1CHS5158 (01)04251285200234(11)210331(21)1CHS5159 (01)04251285200234(11)210331(21)1CHS5160 (01)04251285200234(11)210308(21)1CHS5095 (01)04251285200234(11)210308(21)1CHS5099 (01)04251285200234(11)210301(21)1CHS5076 (01)04251285200234(11)210302(21)1CHS5077 (01)04251285200234(11)210302(21)1CHS5078 (01)04251285200234(11)210218(21)1CHS5060 (01)04251285200234(11)210222(21)1CHS5062 (01)04251285200234(11)210212(21)1CHS5052 (01)04251285200234(11)210212(21)1CHS5054 (01)04251285200234(11)210128(21)1CHS5017 (01)04251285200234(11)210128(21)1CHS5018 (01)04251285200234(11)201021(21)0CHS4818 (01)04251285200234(11)201022(21)0CHS4819 (01)04251285200234(11)201022(21)0CHS4820 (01)04251285200234(11)201009(21)0CHS4795 (01)04251285200234(11)200928(21)0CHS4763 (01)04251285200234(11)200928(21)0CHS4764 (01)04251285200234(11)200928(21)0CHS4765 (01)04251285200234(11)200929(21)0CHS4766 (01)04251285200234(11)200930(21)0CHS4768 (01)04251285200234(11)200923(21)0CHS4756 (01)04251285200234(11)200930(21)0CHS4769 (01)04251285200234(11)201001(21)0CHS4773 (01)04251285200234(11)200916(21)0CHS4717 (01)04251285200234(11)200915(21)0CHS4718 (01)04251285200234(11)200923(21)0CHS4752 (01)04251285200234(11)200922(21)0CHS4753 (01)04251285200234(11)200922(21)0CHS4754 (01)04251285200234(11)200923(21)0CHS4755 (01)04251285200234(11)200921(21)0CHS4757 (01)04251285200234(11)200921(21)0CHS4758 (01)04251285200234(11)200921(21)0CHS4759 (01)04251285200234(11)200921(21)0CHS4760 (01)04251285200234(11)200921(21)0CHS4761 (01)04251285200234(11)200921(21)0CHS4762 (01)04251285200234(11)200917(21)0CHS4719 (01)04251285200234(11)200916(21)0CHS4720 (01)04251285200234(11)200916(21)0CHS4721 (01)04251285200234(11)200916(21)0CHS4722 (01)04251285200234(11)200917(21)0CHS4723 (01)04251285200234(11)200918(21)0CHS4724 (01)04251285200234(11)200917(21)0CHS4654 (01)04251285200234(11)200901(21)0CHS4655 (01)04251285200234(11)200904(21)0CHS4657 (01)04251285200234(11)200904(21)0CHS4668 (01)04251285200234(11)200904(21)0CHS4669 (01)04251285200234(11)200904(21)0CHS4670 (01)04251285200234(11)200908(21)0CHS4671 (01)04251285200234(11)200907(21)0CHS4672 (01)04251285200234(11)200907(21)0CHS4673 (01)04251285200234(11)200901(21)0CHS4638 (01)04251285200234(11)200901(21)0CHS4615 (01)04251285200234(11)200821(21)0CHS4624 (01)04251285200234(11)200727(21)0CHS4533 (01)04251285200234(11)200727(21)0CHS4535 (01)04251285200234(11)200605(21)0CHS4170 (01)04251285200234(11)200609(21)0CHS4195 (01)04251285200234(11)200610(21)0CHS4196 (01)04251285200234(11)200608(21)0CHS4144 (01)04251285200234(11)200608(21)0CHS4146 (01)04251285200234(11)200605(21)0CHS4148 (01)04251285200234(11)200603(21)0CHS4165 (01)04251285200234(11)200603(21)0CHS4166 (01)04251285200234(11)200603(21)0CHS4167 (01)04251285200234(11)200603(21)0CHS4168 (01)04251285200234(11)200604(21)0CHS4169 (01)04251285200234(11)200429(21)0CHS3998 (01)04251285200234(11)200518(21)0CHS4075 (01)04251285200234(11)200512(21)0CHS3993 (01)04251285200234(11)200512(21)0CHS4065 (01)04251285200234(11)200512(21)0CHS4067 (01)04251285200234(11)200512(21)0CHS4068 (01)04251285200234(11)200518(21)0CHS4076 (01)04251285200234(11)200511(21)0CHS4061 (01)04251285200234(11)200429(21)0CHS3994 (01)04251285200234(11)200429(21)0CHS3995 (01)04251285200234(11)200429(21)0CHS3999 (01)04251285200234(11)200429(21)0CHS4000 (01)04251285200234(11)200421(21)0CHS3958 (01)04251285200234(11)200422(21)0CHS3959 (01)04251285200234(11)200422(21)0CHS3983 (01)04251285200234(11)200422(21)0CHS3984 (01)04251285200234(11)200311(21)0CHS3819 (01)04251285200234(11)200311(21)0CHS3820 (01)04251285200234(11)200304(21)0CHS3777 (01)04251285200234(11)200306(21)0CHS3778 (01)04251285200234(11)200304(21)0CHS3779 (01)04251285200234(11)200304(21)0CHS3780 (01)04251285200234(11)200214(21)0CHS3771 (01)04251285200234(11)200214(21)0CHS3772 (01)04251285200234(11)200217(21)0CHS3775 (01)04251285200234(11)200204(21)0CHS3731 (01)04251285200234(11)200130(21)0CHS3724 (01)04251285200234(11)200130(21)0CHS3725 (01)04251285200234(11)200114(21)0CHS3692 (01)04251285200234(11)200122(21)0CHS3693 (01)04251285200234(11)200122(21)0CHS3695 (01)04251285200234(11)200122(21)0CHS3697 (01)04251285200234(11)200114(21)0CHS3662 (01)04251285200234(11)191203(21)9CHS3603 (01)04251285200234(11)191205(21)9CHS3636 (01)04251285200234(11)191205(21)9CHS3601 (01)04251285200234(11)191205(21)9CHS3602 (01)04251285200234(11)191205(21)9CHS3604 (01)04251285200234(11)191122(21)9CHS3575 (01)04251285200234(11)191120(21)9CHS3558 (01)04251285200234(11)191029(21)9CHS3537 (01)04251285200234(11)191021(21)9CHS3505 (01)04251285200234(11)191023(21)9CHS3503 (01)04251285200234(11)191011(21)9CHS3481 (01)04251285200234(11)191008(21)9CHS3451 (01)04251285200234(11)191008(21)9CHS3450 (01)04251285200234(11)191002(21)9CHS3413 (01)04251285200234(11)190925(21)9CHS3392 (01)04251285200234(11)190928(21)9CHS3390 (01)04251285200234(11)190923(21)9CHS3386 (01)04251285200234(11)190912(21)9CHS3354 (01)04251285200234(11)190627(21)9CHS3174 (01)04251285200234(11)190618(21)9CHS3153 (01)04251285200234(11)190618(21)9CHS3154 (01)04251285200234(11)190619(21)9CHS3156 (01)04251285200234(11)190617(21)9CHS3134 (01)04251285200234(11)190603(21)9CHS3104 (01)04251285200234(11)190603(21)9CHS3106 (01)04251285200234(11)190606(21)9CHS3111 (01)04251285200234(11)190606(21)9CHS3112 (01)04251285200234(11)190528(21)9CHS3087 (01)04251285200234(11)190522(21)9CHS3065 (01)04251285200234(11)190516(21)9CHS3039 (01)04251285200234(11)190417(21)9CHS3014 (01)04251285200234(11)190424(21)9CHS3016 (01)04251285200234(11)190423(21)9CHS3018 (01)04251285200234(11)190416(21)9CHS2999 (01)04251285200234(11)190423(21)9CHS3000 (01)04251285200234(11)190416(21)9CHS3001 (01)04251285200234(11)190418(21)9CHS3004 (01)04251285200234(11)190311(21)9CHS2914 (01)04251285200234(11)190311(21)9CHS2915 (01)04251285200234(11)190312(21)9CHS2917 (01)04251285200234(11)190311(21)9CHS2918 (01)04251285200234(11)190311(21)9CHS2919 (01)04251285200234(11)190307(21)9CHS2876 (01)04251285200234(11)190228(21)9CHS2877 (01)04251285200234(11)190304(21)9CHS2878 (01)04251285200234(11)190308(21)9CHS2879 (01)04251285200234(11)190304(21)9CHS2880 (01)04251285200234(11)190305(21)9CHS2890 (01)04251285200234(11)190305(21)9CHS2892 (01)04251285200234(11)190306(21)9CHS2893 (01)04251285200234(11)190306(21)9CHS2894 (01)04251285200234(11)190307(21)9CHS2895 (01)04251285200234(11)190219(21)9CHS2851 (01)04251285200234(11)190219(21)9CHS2852 (01)04251285200234(11)190220(21)9CHS2853 (01)04251285200234(11)190218(21)9CHS2854 (01)04251285200234(11)190219(21)9CHS2855 (01)04251285200234(11)190219(21)9CHS2856 (01)04251285200234(11)190222(21)9CHS2870 (01)04251285200234(11)190222(21)9CHS2871 (01)04251285200234(11)190227(21)9CHS2872 (01)04251285200234(11)190228(21)9CHS2873 (01)04251285200234(11)190304(21)9CHS2874 (01)04251285200234(11)190301(21)9CHS2875 (01)04251285200234(11)190215(21)9CHS2818 (01)04251285200234(11)190219(21)9CHS2821 (01)04251285200234(11)190215(21)9CHS2822 (01)04251285200234(11)190218(21)9CHS2823 (01)04251285200234(11)190220(21)9CHS2845 (01)04251285200234(11)190218(21)9CHS2847 (01)04251285200234(11)190218(21)9CHS2848 (01)04251285200234(11)190220(21)9CHS2850 Serial Numbers: 2CHS5762 1CHS5601 1CHS5602 1CHS5603 1CHS5604 1CHS5605 1CHS5606 1CHS5592 1CHS5595 1CHS5599 1CHS5600 1CHS5607 1CHS5543 1CHS5554 1CHS5558 1CHS5544 1CHS5546 1CHS5547 1CHS5536 1CHS5537 1CHS5538 1CHS5540 1CHS5541 1CHS5565 1CHS5568 1CHS5588 1CHS5572 1CHS5580 1CHS5559 1CHS5561 1CHS5563 1CHS5405 1CHS5372 1CHS5157 0CHS4639 0CHS4641 0CHS4640 0CHS4197 0CHS4078 0CHS4077 0CHS4108 0CHS3976 0CHS3987 0CHS3977 0CHS3986 9CHS3600 9CHS3090 9CHS2916 9CHS2891 9CHS2881 9CHS2819 9CHS2820 2CHS5780 2CHS5763 2CHS5764 2CHS5765 2CHS5766 2CHS5767 1CHS5583 1CHS5584 1CHS5585 1CHS5586 1CHS5596 1CHS5597 1CHS5598 1CHS5555 1CHS5556 1CHS5557 1CHS5542 1CHS5545 1CHS5548 1CHS5539 1CHS5566 1CHS5567 1CHS5569 1CHS5570 1CHS5589 1CHS5590 1CHS5591 1CHS5593 1CHS5594 1CHS5575 1CHS5576 1CHS5578 1CHS5579 1CHS5587 1CHS5573 1CHS5574 1CHS5581 1CHS5582 1CHS5560 1CHS5562 1CHS5564 1CHS5465 1CHS5452 1CHS5455 1CHS5241 1CHS5244 1CHS5246 1CHS5235 1CHS5239 1CHS5170 1CHS5173 1CHS5158 1CHS5159 1CHS5160 1CHS5095 1CHS5099 1CHS5076 1CHS5077 1CHS5078 1CHS5060 1CHS5062 1CHS5052 1CHS5054 1CHS5017 1CHS5018 0CHS4818 0CHS4819 0CHS4820 0CHS4795 0CHS4763 0CHS4764 0CHS4765 0CHS4766 0CHS4768 0CHS4756 0CHS4769 0CHS4773 0CHS4717 0CHS4718 0CHS4752 0CHS4753 0CHS4754 0CHS4755 0CHS4757 0CHS4758 0CHS4759 0CHS4760 0CHS4761 0CHS4762 0CHS4719 0CHS4720 0CHS4721 0CHS4722 0CHS4723 0CHS4724 0CHS4654 0CHS4655 0CHS4657 0CHS4668 0CHS4669 0CHS4670 0CHS4671 0CHS4672 0CHS4673 0CHS4638 0CHS4615 0CHS4624 0CHS4533 0CHS4535 0CHS4170 0CHS4195 0CHS4196 0CHS4144 0CHS4146 0CHS4148 0CHS4165 0CHS4166 0CHS4167 0CHS4168 0CHS4169 0CHS3998 0CHS4075 0CHS3993 0CHS4065 0CHS4067 0CHS4068 0CHS4076 0CHS4061 0CHS3994 0CHS3995 0CHS3999 0CHS4000 0CHS3958 0CHS3959 0CHS3983 0CHS3984 0CHS3819 0CHS3820 0CHS3777 0CHS3778 0CHS3779 0CHS3780 0CHS3771 0CHS3772 0CHS3775 0CHS3731 0CHS3724 0CHS3725 0CHS3692 0CHS3693 0CHS3695 0CHS3697 0CHS3662 9CHS3603 9CHS3636 9CHS3601 9CHS3602 9CHS3604 9CHS3575 9CHS3558 9CHS3537 9CHS3505 9CHS3503 9CHS3481 9CHS3451 9CHS3450 9CHS3413 9CHS3392 9CHS3390 9CHS3386 9CHS3354 9CHS3174 9CHS3153 9CHS3154 9CHS3156 9CHS3134 9CHS3104 9CHS3106 9CHS3111 9CHS3112 9CHS3087 9CHS3065 9CHS3039 9CHS3014 9CHS3016 9CHS3018 9CHS2999 9CHS3000 9CHS3001 9CHS3004 9CHS2914 9CHS2915 9CHS2917 9CHS2918 9CHS2919 9CHS2876 9CHS2877 9CHS2878 9CHS2879 9CHS2880 9CHS2890 9CHS2892 9CHS2893 9CHS2894 9CHS2895 9CHS2851 9CHS2852 9CHS2853 9CHS2854 9CHS2855 9CHS2856 9CHS2870 9CHS2871 9CHS2872 9CHS2873 9CHS2874 9CHS2875 9CHS2818 9CHS2821 9CHS2822 9CHS2823 9CHS2845 9CHS2847 9CHS2848 9CHS2850
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information ContactFresenius Medical Care Technical Service
800-553-1109
Manufacturer 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
FDA Determined
Cause 2
Under Investigation by firm
ActionFresenius Medical issued Urgent Medical Device Correction letter (FA-2022-16-C) on 6/16/22. Letter states reason for recall, health risk and action to take: DO NOT TOUCH THE ETHERNET PORT ON THE BACK OF THE MACHINE. " If your ethernet port cover is not covered by the enclosed cover, unplug the machine, and carefully cover it without touching the ethernet port. " Do not perform any service to the device requiring you to connect an ethernet cable to the device. Do not attempt to download FTP files via the ethernet cable. " You may continue to use the device until the device correction is made. A Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) Water Systems Service Specialist will be contacting you to schedule a correction of your portable Water Treatment system. If choosing to correct via your own Certified AquaC UNO H System Technician, you will need to contact FMCRTG prior to performing the correction. FMCRTG will provide the necessary instruction via a Change Notification. Only a Certified AquaC UNO H System Technician or FMCRTG Water Systems Service Specialist may perform this service. For questions or concerns, please contact FMCRTG Technical Support Services at 888-553-1109.
Quantity in Commerce277 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FIP
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