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Premier
Fresenius Medical Care Holdings, Inc. · Model 050-30034 · UDI-DI 00840861100675
FKX
Prescription
1
510(k) clearances
164,763
Adverse events (3,441 deaths)
51
Recalls
38
Facilities
Description
PREMIER LUER-LOCK Transfer Set - 8 inch
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-28 | Vantive US Healthcare LLC | Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the a |
| 2023-11-15 | Baxter Healthcare Corporation | There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. |
| 2023-10-24 | Fresenius Medical Care Holdings, Inc. | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic. |
| 2023-02-22 | Baxter Healthcare Corporation | The electrical safety testing was not properly performed on the impacted devices and additional testing is required |
| 2022-04-21 | Baxter Healthcare Corporation | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. |
| 2021-06-30 | BAXTER HEALTHCARE CORPORATION | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the U |
| 2021-06-30 | BAXTER HEALTHCARE CORPORATION | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the U |
| 2021-04-28 | Fresenius Medical Care Holdings, Inc. | Exposed to freezing temperatures due to refrigerated truck malfunctions |
| 2020-09-12 | Fresenius Medical Care Holdings, Inc. | The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid |
| 2019-05-29 | Fresenius Medical Care Renal Therapies Group, LLC | Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into t |
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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.