—#195664

Product

AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US

FDA product code: FIP — Subsystem, Water Purification
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K143617
Affected lot / code info: UDI: (01)4251285200234(11)200422(21)0CHS3987 (01)4251285200234(11)200526(21)0CHS4108 (01)4251285200234(11)210623(21)1CHS5372 (01)4251285200234(11)210707(21)1CHS5405 (01)4251285200234(11)190305(21)9CHS2881 (01)4251285200234(11)190529(21)9CHS3090 Serial Numbers: 0CHS3987 0CHS4108 1CHS5372 1CHS5405 9CHS2881 9CHS3090

Why it was recalled

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Bld 950, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.

Timeline

Recall initiated: 2022-06-21
Posted by FDA: 2022-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195664. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.