—#207965

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

FDA product code: FIP — Subsystem, Water Purification
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K143617
Affected lot / code info: UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 product.complaints@fmc-na.com 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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution in the states of AL, IN, AK, WI.

Timeline

Recall initiated: 2024-05-16
Posted by FDA: 2024-06-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207965. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.