Home › Device types › FIP
Subsystem, Water Purification
FDA product code FIP · Class 2 · Gastroenterology, Urology
889
Registered devices
696
Adverse events
15
Recalls
117
510(k) clearances
Devices with this code
FiberFlo — MEDIVATORS INC.Organic Scavenger — SPECIALITY WATER TECHNOLOGYBioPure 4400 RO — MAR COR PURIFICATION, INC.MEDI-PORT PBII R.O. 220V — BETTER WATER, LLC3046RO, 19800GPD, 208V, 11MEM — BETTER WATER, LLCFiberFlo — MEDIVATORS INC.Shelco Filtration System — SPECIALITY WATER TECHNOLOGYUltrafiltration for High Purity Distribution — SPECIALITY WATER TECHNOLOGYUltraViolet Light Disinfection System — SPECIALITY WATER TECHNOLOGYOrganic Scavenger — SPECIALITY WATER TECHNOLOGYFiberFlo — MEDIVATORS INC.Aquaboss® — B.Braun Avitum AGBioPure 4400 RO — Biolab Equipment LtdAquaBplus — VIVONIC GmbHCarbon Filter Tank — SPECIALITY WATER TECHNOLOGYMD490 Reverse Osmosis System — Isopure, Corp.Aquaboss® — B.Braun Avitum AGBioPure 4400 RO — MAR COR PURIFICATION, INC.23 G — MAR COR PURIFICATION, INC.De-Alkalizer — SPECIALITY WATER TECHNOLOGYUltrafilter U 9000 — Gambro Dialysatoren GmbHFiberFlo — MEDIVATORS INC.Softener Tank — SPECIALITY WATER TECHNOLOGYFiberFlo — MEDIVATORS INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-16 | Fresenius Medical Care Holdings, Inc. | 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 pre |
| 2023-01-24 | Outset Medical, Inc. | An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process. |
| 2022-06-21 | Fresenius Medical Care Holdings, Inc. | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| 2022-06-21 | Fresenius Medical Care Holdings, Inc. | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured |
| 2022-06-16 | Fresenius Medical Care Holdings, Inc. | Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet ca |
| 2022-06-16 | Fresenius Medical Care Holdings, Inc. | Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet ca |
| 2021-08-03 | Fresenius Medical Care Holdings, Inc. | AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may b |
| 2021-03-18 | Fresenius Medical Care Holdings, Inc. | AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may b |
| 2020-09-01 | Fresenius Medical Care Holdings, Inc. | Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, the |
| 2014-04-24 | Mar Cor Purification | Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potent |
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