MarCor ENX Hollow Fiber Capsule UltraFilter
NEPHROS, INC. · Model W2T912244 · UDI-DI 00896241002732
Description
The MarCor ENX Hollow Fiber Capsule UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.). Use: The device is intended for long term continuous use. Once it completes its useful life, the filter should be replaced and discarded. Do not attempt to sterilize or reuse it. CONTRAINDICATIONS Medical: While the MarCor ENX produces ultrapure water, the water is not intended to be used in medical applications where USP sterile water is normally used. Chemical: The MarCor ENX retains biological contaminants. To obtain chemically pure water it is necessary to use the filter in conjunction with other devices such as DI beds or RO systems.
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 pressure alarm limit ex |
| 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 cable conducting elect |
| 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 cable conducting elect |
| 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 be installed in combi |
| 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 be installed in combi |
| 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, these crimp connections |
| 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 potential situation with a |
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