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CYCLER DRAINAGE BAG
BAXTER HEALTHCARE CORPORATION · Model 5C4145NS · UDI-DI 07332414207939
KDJ
Prescription
1
510(k) clearances
72,474
Adverse events (2,405 deaths)
61
Recalls
22
Facilities
Description
The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Vantive Automated Peritoneal Dialysis (APD) Cycler Tubing Sets.
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.