Home › Device types › LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
FDA product code LKN · Class U · Unknown
28
Registered devices
2,769
Adverse events
12
Recalls
27
510(k) clearances
Devices with this code
COBE® 2991 — TERUMO BCT, INC.NXSTAGE TPE CARTRIDGE — NXSTAGE MEDICAL, INC.AMICUS Separator Software — Fresenius Kabi AGSpectra Optia® — TERUMO BCT, INC.AMICUS Separator Life Extension Software — Fresenius Kabi AGBlood Component Filter Set with Vented Spike and Luer Adapter — Fresenius Kabi AGSpectra Optia® — TERUMO BCT, INC.COBE® 2991 — TERUMO BCT, INC.Blood Component Filter Set with Vented Spike and Luer Adapter — Fresenius Kabi AGAMICUS Separator Legacy Software — Fresenius Kabi AGAMICUS Separator Legacy Software — Fresenius Kabi AGCOBE® Spectra — TERUMO BCT, INC.AMICUS Separator — Fresenius Kabi AGSpectra Optia® — TERUMO BCT, INC.AMICUS Exchange Kit — Fresenius Kabi AGAMICUS Separator Life Extension Software — Fresenius Kabi AGHAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM — HAEMONETICS CORPORATIONCOM.TEC — Fresenius Kabi AGWaste Transfer Set — Fresenius Kabi AGAMICUS Exchange Kit - Therapeutics — Fresenius Kabi AGAMICUS Separator — Fresenius Kabi AGAMICUS Separator Life Extension Software — Fresenius Kabi AGDiapact® — B.Braun Avitum AGCOBE® 2991 — TERUMO BCT, INC.
Recent 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 Se |
| 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 Se |
| 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 |
| 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 |
| 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 |
| 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 us |
| 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 corr |
| 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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