10 results
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31ms
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Sources: EU EUDAMED, US FDA
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AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
FDA Enforcement
Class II
·Terminated·Fenwal Inc·June 19, 2013
Vacuum 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.
FDA Enforcement
Class II
·Terminated·Fenwal Inc·April 3, 2019
Fresenius 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 ATF-120 Fast Start Kits (AT-3), or 9108444 ATF-40 Fast Start Kits AT-3) Product Usage: The Fresenius Kabi CATSmart device (Continuous auto transfusion System) is indicated for the processing of autologous shed blood collected interaoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The CATSmart Auto transfusion System is designed to reduce the need for allogeneic blood transfusion by re-infusing a patient s own lost blood during surgery. The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous re-infused blood (auto transfusion). This is a single-use device.
FDA Enforcement
Class II
·Terminated·Fenwal Inc·May 1, 2019
Vigilant 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 is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the Volumat MC Agilia infusion pumps. Intended patient population: The Vigilant Drug Lib software must only be used to create drug libraries for patients whose weight is 250g to 250 kg (0.6 lbs. to 551 lbs.).
FDA Enforcement
Class I
·Terminated·Fenwal Inc·August 21, 2019
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 adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required. Volumat MC Agilia can be used with the Dose Error Reduction Software (DERS) Vigilant Drug Lib to define the default and upper hard limits for the Bolus Volume, or dose, by drug. The health care professional can then operate the pump for that drug within the upper hard limits defined in the Drug Library.
FDA Enforcement
Class I
·Terminated·Fenwal Inc·August 21, 2019
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
FDA Enforcement
Class II
·Terminated·Fenwal Inc·April 14, 2021
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
FDA Enforcement
Class II
·Terminated·Fenwal Inc·April 14, 2021
Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
FDA Enforcement
Class II
·Terminated·Fenwal Inc·April 14, 2021
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
FDA Enforcement
Class II
·Ongoing·Fenwal Inc·March 22, 2023
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
FDA Enforcement
Class II
·Ongoing·Fenwal Inc·March 22, 2023