Recall archive
200 recalls · page 8 of 9
Reported Sep 30, 2015
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
FDA (openFDA drug enforcement)
Reported Aug 26, 2015
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 19, 2015
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter,…
FDA (openFDA drug enforcement)
Reported Jul 15, 2015
0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 17, 2015
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product details — Subpotent Drug; out of specification results for heparin raw material
FDA (openFDA drug enforcement)
Reported Apr 15, 2015
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible…
FDA (openFDA drug enforcement)
Reported Apr 8, 2015
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product details — Lack of Assurance of Sterility; increased complaints received for leaks
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 1, 2015
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Dec 31, 2014
Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Corporation Englewood
Matched: Brand · Product · Product details · Reason for recall — Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the…
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product details — Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
FDA (openFDA drug enforcement)
Reported Dec 17, 2014
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product details · Reason for recall — Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as…
FDA (openFDA drug enforcement)
Reported Sep 24, 2014
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corp.
Matched: Brand · Product details — Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 17, 2014
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility; complaints of mold in the overpouch
FDA (openFDA drug enforcement)
Reported Sep 17, 2014
***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details · Reason for recall — Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 27, 2014
0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
FDA (openFDA drug enforcement)
Reported Aug 27, 2014
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine…
FDA (openFDA drug enforcement)
Reported Aug 6, 2014
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product details · Reason for recall — Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during…
FDA (openFDA device enforcement)
Reported Jul 23, 2014
Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Inadequate iodine and packaging related defects.
FDA (openFDA device enforcement)
Reported May 7, 2014
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 30, 2014
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corp.
Matched: Brand · Reason for recall — Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to…
FDA (openFDA device enforcement)
Reported Mar 26, 2014
Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corp.
Matched: Brand · Product details — Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 25, 2013
ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Corporation Englewood
Matched: Brand · Reason for recall — Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through…
FDA (openFDA device enforcement)
Reported Dec 25, 2013
10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
FDA (openFDA drug enforcement)
Reported Dec 4, 2013
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Product · Product details — Incomplete foil seal on one lot of sterile product.
FDA (openFDA device enforcement)
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