Recall Register

Fenwal Inc: FDA recalls

FDA enforcement reports name Fenwal Inc as the recalling firm in 6 events. The events have 10 product records. The recalls started from 2013 to 2023. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

6 events, newest first.

FDA enforcement events of Fenwal Inc
InitiatedProduct (first record)TypeClassRecordsStatus
14 Feb 2023Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platformDeviceClass II2Ongoing
25 Feb 2021Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.DeviceClass II3Terminated
24 Jun 2019VOLUMAT 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…DeviceClass I2Terminated
5 Mar 2019Fresenius 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…DeviceClass II1Terminated
11 Feb 2019Vacuum 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.DeviceClass II1Terminated
24 May 2013AMICUS 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.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Fenwal Inc: events for each product type
TypeEvents
Device6
Fenwal Inc: events in each class
ClassEvents
Class II5
Class I1
Share of the events of the firm in Class I
17%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Fenwal Inc, by the year that the recall started. The largest year is 2019, with 3 events.

Official channels

Cite this page

Recall Register. Fenwal Inc: FDA recalls. https://recallregister.com/firm/fenwal-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
IL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Fenwal Inc have?
Class II: 5 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Fenwal Inc?
FDA event 91704, which the firm started on 14 Feb 2023. The first product in the record is: Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
How many FDA recalls of Fenwal Inc have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.