Fenwal Inc
FDA Regulatory Profile
Fenwal Inc appears in FDA public data with 10 recalls — including 2 Class I (most serious) —, 3 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1255-2023, Class II) was initiated on February 14, 2023. Its most recent 510(k) clearance was granted on June 10, 2014.
Summary
- Total Recalls
- 10 (2 Class I)
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1255-2023 | Class II | Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform | February 14, 2023 |
| Z-1254-2023 | Class II | Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis pl | February 14, 2023 |
| Z-1344-2021 | Class II | Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mono | February 25, 2021 |
| Z-1343-2021 | Class II | Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of bloo | February 25, 2021 |
| Z-1345-2021 | Class II | Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood compon | February 25, 2021 |
| Z-2065-2019 | Class I | Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Dr | June 24, 2019 |
| Z-2064-2019 | Class I | VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: | June 24, 2019 |
| Z-1209-2019 | Class II | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: | March 5, 2019 |
| Z-1059-2019 | Class II | Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is i | February 11, 2019 |
| Z-1523-2013 | Class II | AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for | May 24, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141019 | AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED | June 10, 2014 |
| K111702 | AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE | March 22, 2012 |
| K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTO | March 3, 2008 |