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Automated PD Set DS-1.B
BYONYKS PRIVATE LIMITED · Model 1F1501 · UDI-DI 08964004471032
KDJ
Prescription
10
510(k) clearances
72,474
Adverse events (2,405 deaths)
61
Recalls
22
Facilities
Description
This Byonyks Automated PD Set DS-1.B is compatible with the Byonyks X-1 APD Cycler.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 | Baxter Healthcare Corporation | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
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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.