Recall archive
197 recalls · page 7 of 9
Reported May 16, 2018
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 11, 2018
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the…
FDA (openFDA device enforcement)
Reported Mar 21, 2018
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the…
FDA (openFDA device enforcement)
Reported Mar 7, 2018
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume…
FDA (openFDA device enforcement)
Reported Feb 7, 2018
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand — A leak may allow for microbial contamination of the sterile fluid path.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2018
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the…
FDA (openFDA device enforcement)
Reported Nov 1, 2017
Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
Matched: Brand · Product details — Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on…
FDA (openFDA drug enforcement)
Reported Aug 23, 2017
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2017
0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL…
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: Customer complaints for leaking bags.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 14, 2017
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may…
FDA (openFDA device enforcement)
Reported May 24, 2017
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, 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: customer complaints received for the presence of leaks.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 5, 2017
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error…
FDA (openFDA device enforcement)
Reported Feb 1, 2017
Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Reason for recall — Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2017
APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product details — Customer complaints received for the presence of leaks
FDA (openFDA device enforcement)
Reported Jan 18, 2017
10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
Matched: Brand · Product · Product details — Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid…
FDA (openFDA drug enforcement)
Reported Dec 28, 2016
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, 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: confirmed customer complaints of leaking bags.
FDA (openFDA drug enforcement)
Reported Oct 12, 2016
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Corporation Englewood
Matched: Brand · Product details · Reason for recall — Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due…
FDA (openFDA device enforcement)
Reported Jun 15, 2016
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare…
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 compliants of finding an insect floating in the primary container of each product.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jun 1, 2016
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter…
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: potential for leaking containers which lacks the assurance of sterility.
3 more products in this recall
FDA (openFDA drug enforcement)
Reported May 4, 2016
Automated peritoneal dialysis (APD) cycler
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corp.
Matched: Brand · Reason for recall — Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO)…
FDA (openFDA device enforcement)
Reported Mar 9, 2016
0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015,…
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: Product complaint for the presence of particulate matter identified as an insect.
FDA (openFDA drug enforcement)
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)
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