FDAFebruary 25, 2021device
Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
What to do
FDA enforcement status: Terminated
Brands named
fenwal
UPCs
04086000101950
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAmicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform2023-02-14
- FDAAmicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform2023-02-14
- FDAAmicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.2021-02-25
- FDAAmicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.2021-02-25
- FDAVigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia i...2019-06-24
- FDAVOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adult...2019-06-24
- FDAFresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 AT...2019-03-05
- FDAVacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.2019-02-11
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