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Fenwal AMICUS Double Needle Advanced Kit
Fresenius Kabi AG · Model 4R2354 · UDI-DI 04086000101387
GKT
Prescription
10
510(k) clearances
6,575
Adverse events (264 deaths)
1
Recalls
39
Facilities
Description
For Collection of Platelets with Optional Plasma. 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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