Fenwal Recalls
10 recalls on record · June 19, 2013 to March 22, 2023 · Medical Devices
Recalls by year
13
19
21
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 22, 2023Medical DevicesFDA
Fenwal Inc recalls Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Hazard: Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
March 22, 2023Medical DevicesFDA
Fenwal Inc recalls Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Hazard: Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
April 14, 2021Medical DevicesFDA
Fenwal Inc recalls Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear
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.
April 14, 2021Medical DevicesFDA
Fenwal Inc recalls Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
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.
April 14, 2021Medical DevicesFDA
Fenwal Inc recalls Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mon
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.
August 21, 2019Medical DevicesFDA
Fenwal Inc recalls Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Erro
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
August 21, 2019Medical DevicesFDA
Fenwal Inc recalls VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agili
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
May 1, 2019Medical DevicesFDA
Fenwal Inc recalls Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets an
Hazard: Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result in the centrifuge tubing line making contact with the washing chamber. The contact may result in excessive wear of the centrifuge tubing or in extreme cases a puncture of the tubing.
April 3, 2019Medical DevicesFDA
Fenwal Inc recalls Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the pro
Hazard: The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
June 19, 2013Medical DevicesFDA
Fenwal Inc recalls AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plas
Hazard: Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s