Baxter Englewood recalls
Baxter Englewood appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2016-10-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2013-12-25 to 2016-10-12 |
| By agency | FDA Device (9) |
| By classification | Class II (7), Class I (2) |
| By status | terminated (9) |
| Distribution named in notices | AL, AZ, CA, CT, FL, GA, HI, IL, KS, MA, MI, MN, MO, NC, NV, OH, OR, PA, TN, TX, US, UT, VA, WI |
Recalls
- 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions
FDA Device · Class I · 2016-10-12 · Baxter Englewood
Reason: Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for pa… - Baxter, RAPIDFILL Syringe Strip, 10 ml
FDA Device · Class II · 2016-02-10 · Baxter Englewood
Reason: All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product. - ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based orde…
FDA Device · Class II · 2015-05-27 · Baxter Englewood
Reason: Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula f… - Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps
FDA Device · Class II · 2015-03-11 · Baxter Englewood
Reason: Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels. - Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Eng…
FDA Device · Class II · 2014-12-31 · Baxter Englewood
Reason: Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation. - Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding
FDA Device · Class II · 2014-07-02 · Baxter Englewood
Reason: Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may displ… - ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition),…
FDA Device · Class I · 2014-05-21 · Baxter Englewood
Reason: 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volu… - RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White
FDA Device · Class II · 2014-05-21 · Baxter Englewood
Reason: Possible breach in sterile barrier for inner and outer bags of the product. - ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-004…
FDA Device · Class II · 2013-12-25 · Baxter Englewood
Reason: Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility that a patient could receive another patie…