Date Initiated by Firm | June 16, 2022 |
Date Posted | July 25, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1463-2022 |
Recall Event ID |
90527 |
510(K)Number | K143617 |
Product Classification |
Subsystem, water purification - Product Code FIP
|
Product | AquaC 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
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(01)04251285200234(11)211004(21)1CHS5599
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(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
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(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
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(01)04251285200234(11)200523(21)0CHS4078
(01)04251285200234(11)200522(21)0CHS4077
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(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
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(01)04251285200234(11)220126(21)2CHS5764
(01)04251285200234(11)220127(21)2CHS5765
(01)04251285200234(11)220203(21)2CHS5766
(01)04251285200234(11)220203(21)2CHS5767
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(01)04251285200234(11)210915(21)1CHS5557
(01)04251285200234(11)210909(21)1CHS5542
(01)04251285200234(11)210908(21)1CHS5545
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(01)04251285200234(11)210929(21)1CHS5589
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(01)04251285200234(11)210929(21)1CHS5591
(01)04251285200234(11)210929(21)1CHS5593
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(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
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(01)04251285200234(11)210503(21)1CHS5241
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(01)04251285200234(11)210503(21)1CHS5246
(01)04251285200234(11)210428(21)1CHS5235
(01)04251285200234(11)210428(21)1CHS5239
(01)04251285200234(11)210414(21)1CHS5170
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(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
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(01)04251285200234(11)201022(21)0CHS4820
(01)04251285200234(11)201009(21)0CHS4795
(01)04251285200234(11)200928(21)0CHS4763
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(01)04251285200234(11)200928(21)0CHS4765
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(01)04251285200234(11)200727(21)0CHS4533
(01)04251285200234(11)200727(21)0CHS4535
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(01)04251285200234(11)191203(21)9CHS3603
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(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
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0CHS4639
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0CHS3987
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0CHS3986
9CHS3600
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2CHS5780
2CHS5763
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1CHS5583
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1CHS5591
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0CHS4818
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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
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Recalling Firm/ Manufacturer |
Fresenius Medical Care Holdings, Inc. 920 Winter St Bld 950 Waltham MA 02451-1521
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For Additional Information Contact | Fresenius 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 |
Action | Fresenius 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 Commerce | 277 units |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FIP
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