Home › Fresenius Kabi AG › AMICUS Exchange Kit - Therapeutics
AMICUS Exchange Kit - Therapeutics
Fresenius Kabi AG · Model X6R2349 · UDI-DI 04086000101950
LKN
Prescription
1
510(k) clearances
2,769
Adverse events (106 deaths)
12
Recalls
20
Facilities
Description
For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.