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Fenwal AMICUS Single Needle Advanced Kit
Fresenius Kabi AG · Model 4R2353 · UDI-DI 04086000101370
GKT
Prescription
10
510(k) clearances
6,581
Adverse events (266 deaths)
1
Recalls
39
Facilities
Description
For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. 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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