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PLASMACELL Xi Disposable Set with SPIKESMART
Fresenius Kabi AG · Model 6R2600P · UDI-DI 00810020441116
GKT
Prescription
10
510(k) clearances
6,581
Adverse events (266 deaths)
1
Recalls
39
Facilities
Description
For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-25 | Fenwal Inc | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is |
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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.