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Ultrafilter U 9000

Gambro Dialysatoren GmbH · Model 112062 · UDI-DI 07332414102500

FIP Prescription

510(k) clearances

697

Adverse events (9 deaths)

Recalls

Facilities

Description

The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized.

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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Data 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.