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CompoDock
Fresenius Kabi AG · Model 9028721 · UDI-DI 04086000860215
6
510(k) clearances
71
Adverse events (2 deaths)
11
Recalls
19
Facilities
Description
The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide protection against microbial contamination. The CompoDock is a high-frequency connection device that permits sterile connection of medical PVC tubes to one another. Here, sterile connection is achieved when germs from the environment are prevented from being carried into the closed systems. The closed system is maintained after the docking process.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2003-07-16 | Baxter Healthcare Corp. | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
| 2002-12-18 | Baxter Healthcare Corp. | Leakage may occur at the inlet port |
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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.