Recall Z-2141-2024 ยท FIP Subsystem, Water Purification
Fresenius Medical Care Holdings, Inc.
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
| Date | Jun 13, 2024 (initiated May 16, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 product.complaints@fmc-na.com or FDA MedWatchathttps://www.fda.go |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of AL, IN, AK, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143617 | AquaC UNO H Vivonic GmbH, Oct 19, 2015 |