Z-2141-2024Class II

US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic...

Name: Z-2141-2024 US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2024-05-16
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2024-05-16 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number... on 2024-05-16. FDA classified it as Class II and gives the reason as "Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2141-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-16
Posted: 2024-06-13
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Product code: FIP Subsystem, Water Purification
Reason for recall: Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fresenius Medical issued Urgent Medical Device Correction letter on 5-16-2024. Letter states reason for recall, health risk and action to take: A Fresenius Medical Care Water Systems Service Specialist will be contacting you to schedule an evaluation of your Water Treatment system and provide feedback on your system. For questions or concerns, please contact Fresenius Medical Care Technical Services at 800-227-2572, OPTION 4. " Please provide this letter to your Biomedical Technician " Report any complaints or adverse events to [email protected] or FDA MedWatchathttps://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting. " Provide this Customer Notice to all those who need to be aware within your organization. " Complete and return the attached reply form.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of AL, IN, AK, WI.
Product codes and lots: UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2141-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2141-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-13

Product code FIP

K143617Class IIAquaC UNO HVivonic GmbH / cleared 2015-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)