Baxter Corporation Englewood
FDA Regulatory Profile
Summary
- Total Recalls
- 9 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0007-2017 | Class I | 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filt | August 24, 2016 |
| Z-0731-2016 | Class II | Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF) | December 21, 2015 |
| Z-1628-2015 | Class II | ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: | April 8, 2015 |
| Z-1227-2015 | Class II | Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866 | December 29, 2014 |
| Z-0871-2015 | Class II | Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcar | December 4, 2014 |
| Z-1847-2014 | Class II | Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compo | May 28, 2014 |
| Z-1620-2014 | Class II | RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL | April 16, 2014 |
| Z-1566-2014 | Class I | ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 | April 2, 2014 |
| Z-0539-2014 | Class II | ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE | December 3, 2013 |