FDAJune 24, 2019device
VOLUMAT 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib
What to do
FDA enforcement status: Terminated
Brands named
fenwal
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAmicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform2023-02-14
- FDAAmicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform2023-02-14
- FDAAmicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.2021-02-25
- 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
- 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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