Home › Device types › FIP
Subsystem, Water Purification
FDA product code FIP · Class 2 · Gastroenterology, Urology
0
Registered devices
699
Adverse events
15
Recalls
117
510(k) clearances
Devices with this code
AmeriWater MRO2X — AMERIWATER, LLCAquaboss® — B.Braun Avitum AGBioPure 4400 RO — MAR COR PURIFICATION, INC.FiberFlo — MEDIVATORS INC.3046RO, 14400GPD, 208V, 8MEM — BETTER WATER, LLCFiberFlo — MEDIVATORS INC.BioPure 4400 RO — MAR COR PURIFICATION, INC.FiberFlo — MEDIVATORS INC.700 Series — MAR COR PURIFICATION, INC.Posiclear — MAR COR PURIFICATION, INC.FiberFlo — MEDIVATORS INC.Shelco Filtration System — SPECIALITY WATER TECHNOLOGYAmeriWater MRO5X — AMERIWATER, LLCFiberFlo — MEDIVATORS INC.Shelco Filtration System — SPECIALITY WATER TECHNOLOGY3046RO, 19800GPD, 460V, 11MEM — BETTER WATER, LLCSteriChek® Total Chlorine Test Kit — HACH COMPANY23 G — MAR COR PURIFICATION, INC.BioPure 4400 RO — Biolab Equipment LtdAquaboss® — B.Braun Avitum AGSoftener Tank — SPECIALITY WATER TECHNOLOGYBioPure 4400 RO — Biolab Equipment LtdModa-flx Hemodialysis System — Diality IncBioPure HX2 — Biolab Equipment Ltd
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.