Recall Register

Baxter Corporation Englewood: FDA recalls

FDA enforcement reports name Baxter Corporation Englewood as the recalling firm in 9 events. The events have 9 product records. The recalls started from 2013 to 2016. 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

9 events, newest first.

FDA enforcement events of Baxter Corporation Englewood
InitiatedProduct (first record)TypeClassRecordsStatus
24 Aug 20160.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.DeviceClass I1Terminated
21 Dec 2015Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)DeviceClass II1Terminated
8 Apr 2015ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.DeviceClass II1Terminated
29 Dec 2014Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025,…DeviceClass II1Terminated
4 Dec 2014Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. SterileDeviceClass II1Terminated
28 May 2014Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.DeviceClass II1Terminated
16 Apr 2014RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe…DeviceClass II1Terminated
2 Apr 2014ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE,…DeviceClass I1Terminated
3 Dec 2013ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of…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

Baxter Corporation Englewood: events for each product type
TypeEvents
Device9
Baxter Corporation Englewood: events in each class
ClassEvents
Class II7
Class I2
Share of the events of the firm in Class I
22%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

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 Baxter Corporation Englewood, by the year that the recall started. The largest year is 2014, with 5 events.

Official channels

Cite this page

Recall Register. Baxter Corporation Englewood: FDA recalls. https://recallregister.com/firm/baxter-corporation-englewood/. 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
CO

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 Baxter Corporation Englewood have?
Class II: 7 events. Class I: 2 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Baxter Corporation Englewood?
FDA event 75031, which the firm started on 24 Aug 2016. The first product in the record is: 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
How many FDA recalls of Baxter Corporation Englewood have the status Ongoing?
No 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.