Fenwal Inc recalls

9 recalls on record · latest: February 14, 2023

Official U.S. recall history for Fenwal Inc, compiled from official government records.

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Fenwal Inc recalls Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

February 14, 2023 · Medical device recalls Moderate risk Potential for centrifuge packs to develop a stress leak for certain lots of Ami…

Fenwal Inc recalls Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform

February 14, 2023 · Medical device recalls Moderate risk Potential for centrifuge packs to develop a stress leak for certain lots of Ami…

Fenwal Inc recalls Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.

February 25, 2021 · Medical device recalls Moderate risk Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrif…

Fenwal Inc recalls Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mo…

February 25, 2021 · Medical device recalls Moderate risk Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrif…

Fenwal Inc recalls Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclea…

February 25, 2021 · Medical device recalls Moderate risk Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrif…

Fenwal Inc recalls Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Re…

June 24, 2019 · Medical device recalls High risk The firm is correcting four software anomalies and KVO (keep vein open) end of…

Fenwal Inc recalls VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia i…

June 24, 2019 · Medical device recalls High risk The firm is correcting four software anomalies and KVO (keep vein open) end of…

Fenwal Inc recalls Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kit…

March 5, 2019 · Medical device recalls Moderate risk Based on internal investigations, Fresenius Kabi has identified a multifaceted…

Fenwal Inc recalls Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the proce…

February 11, 2019 · Medical device recalls Moderate risk The optional Vacuum Unit may stop working and display the failure message "Fail…