Lake Zurich, IL, United States
Fenwal Inc recalls
5 recalls recorded since 2018, most recently on 14 February 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 14 February 2023
- Reason
- 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.
- Distribution
- Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1255-2023, Z-1254-2023
- Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
- Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Terminated Class II Medical devices
- Recall started
- 25 February 2021
- Terminated
- 18 April 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1344-2021, Z-1343-2021, Z-1345-2021
- Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
- Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
- Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Terminated Class I Medical devices
- Recall started
- 24 June 2019
- Terminated
- 6 March 2023
- Reason
- 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
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2065-2019, Z-2064-2019
- 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 intend
- 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 environ
Terminated Class II Medical devices
- Recall started
- 5 March 2019
- Terminated
- 5 October 2020
- Reason
- 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.
- Distribution
- Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and PR, and country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1209-2019
- 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
Terminated Class II Medical devices
- Recall started
- 11 February 2019
- Terminated
- 23 June 2020
- Reason
- The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
- Distribution
- US Nationwide Distribution to states of: AZ, CA, FL, HI, ID, IL, IN, MD, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OK, OR, PA, TN, TX, VA and PR; and Internationally to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1059-2019
- 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 ce
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.