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Fenwal Plasma Transfer Sets with Two Spikes
Fresenius Kabi AG · Model 4C2243 · UDI-DI 14052682004169
KSB
Prescription
6
510(k) clearances
71
Adverse events (2 deaths)
11
Recalls
19
Facilities
Description
Plasma Transfer Sets with Two Spikes. Sterile Fluid Path
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.