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FENWAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 3 CORPORATE DR STE 300, LAKE ZURICH, IL, 60047
Website: xx.xx
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-933-6925
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004548776
DUNS Number: 794519020

Catalogue (20)

Device	Model / Reference	Registries	Class	Status
Transfer Pack	4R2001	FDA UDI	Class II	Unknown
ALYX 2RBC LR Kit with Saline Spike	4R5742	FDA UDI	Class II	Active
Transfer Pack	4R2014	FDA UDI	Class II	Unknown
Fenwal DXT Relay	2.2	FDA UDI	Class II	Active
Apheresis Needle with MASTERGUARD Protector	4R2441	FDA UDI	Class II	Unknown
ALYX™ 2RBC-LR Kit	4R5720	FDA UDI	Class II	Active
Fenwal DXT Relay Release 2.2	5S9803	FDA UDI	Class II	Active
ALYX Plasma Kit	4R5730	FDA UDI	Class II	Unknown
Transfer Pack	4R2023	FDA UDI	Class II	Unknown
ALYX™ RBC/Plasma Kit	4R5700	FDA UDI	Class II	Active
Transfer Pack	4R2024	FDA UDI	Class II	Unknown
Apheresis Needle with MASTERGUARD™ Protector	4R2440	FDA UDI	Class II	Unknown
Leukoconnect	4C4300	FDA UDI	Class II	Unknown
Transfer Pack	4R2027	FDA UDI	Class II	Unknown
Transfer Pack	4R2032	FDA UDI	Class II	Unknown
Transfer Pack	4R2004	FDA UDI	Class II	Unknown
Amicus Separator System- Use In Therapeutic Plasma Exchange And Filter Set For Amicus Tpe	K111702	FDA 510(k)	U	Active
Blood Component Recipient Set With Standard Size Filter And Infusion Set With Side Arm Luer Connector	K073339	FDA 510(k)	Class II	Active
Amicus Separator System/ Amicus Seperator System;refurbished	K141019	FDA 510(k)	U	Active
Plasma Separation System	P820032	FDA PMA	U	Active

Related Companies

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 14, 2023	Z-1255-2023	—	open, classified	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.
Feb 14, 2023	Z-1254-2023	—	open, classified	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.
Feb 25, 2021	Z-1345-2021	—	terminated	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.
Feb 25, 2021	Z-1344-2021	—	terminated	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.
Feb 25, 2021	Z-1343-2021	—	terminated	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.
Jun 24, 2019	Z-2065-2019	—	terminated	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
Jun 24, 2019	Z-2064-2019	—	terminated	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
Mar 5, 2019	Z-1209-2019	—	terminated	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.
Feb 11, 2019	Z-1059-2019	—	terminated	The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
May 24, 2013	Z-1523-2013	—	terminated	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