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AMICUS Exchange Kit
Fresenius Kabi AG · Model X6R2339 · UDI-DI 04086000100151
LKN
Prescription
1
510(k) clearances
2,769
Adverse events (106 deaths)
12
Recalls
20
Facilities
Description
For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Sterile Fluid Path.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-14 | Fenwal Inc | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator. |
| 2023-02-14 | Fenwal Inc | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator. |
| 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 |
| 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 |
| 2013-05-24 | Fenwal Inc | Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Produ |
| 2012-05-04 | CaridianBCT, Inc. | Defective product may result in decreased efficacy. |
| 2011-10-26 | CaridianBCT, Inc. | Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed. |
| 2011-09-21 | Caridian BCT, Incorporated | Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis. |
| 2011-04-19 | Fresenius Kabi, LLC | Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and re |
| 2010-12-09 | Caridian BCT, Incorporated | An additional air detection system is being added to all existing systems to detect air in the system's return line. |
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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.