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BioPure 4400 RO
MAR COR PURIFICATION, INC. · Model 105M16B2E · UDI-DI 00817492021990
FIP
Prescription
10
510(k) clearances
696
Adverse events (9 deaths)
15
Recalls
58
Facilities
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.