| | Class 2 Device Recall Fresenius AquaC UNO H |  |
| Date Initiated by Firm | June 21, 2022 |
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| Date Posted | September 19, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1769-2022 |
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| Recall Event ID |
90757 |
| 510(K)Number | K143617 |
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| Product Classification |
Subsystem, water purification - Product Code FIP
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| Product | 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 |
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| Code Information |
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
|
Recalling Firm/
Manufacturer |
Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
|
| For Additional Information Contact | SAMe
781-6999580 |
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Manufacturer Reason
for Recall | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) issued Urgent Medical Deice Correction letter (FA-2022-20-C) on 06/21/22 via First Class Mail. Letter states reason for recall, health risk and action to take:
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. Only a Certified AquaC UNO H System Technician or FMCRTG Water Systems Service
Specialist may perform this service. 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.
For questions or concerns, please contact FMCRTG Technical Support Services at 888-553-1109. |
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| Quantity in Commerce | 24 units |
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| Distribution | US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.
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| 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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