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Baxter Healthcare Recalls
556 recalls on record · June 20, 2012 to August 19, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 6, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corpor
Hazard: Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
November 6, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Ad
Hazard: The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
August 7, 2013DrugsFDA
Baxter Healthcare Corp. recalls DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Heal
Hazard: Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
July 17, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Len
Hazard: A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
July 17, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Len
Hazard: A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
July 17, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2
Hazard: A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
July 17, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medicatio
Hazard: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage
July 17, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medicatio
Hazard: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage
July 17, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medicatio
Hazard: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage
July 10, 2013DrugsFDA
Baxter Healthcare Corp. recalls Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Hazard: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
July 10, 2013DrugsFDA
Baxter Healthcare Corp. recalls Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B13
Hazard: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
July 10, 2013DrugsFDA
Baxter Healthcare Corp. recalls Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerf
Hazard: Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
July 10, 2013DrugsFDA
Baxter Healthcare Corp. recalls Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000m
Hazard: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
July 10, 2013DrugsFDA
Baxter Healthcare Corp. recalls 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (ND
Hazard: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
July 10, 2013DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-1
Hazard: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day
Hazard: Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Devic
Hazard: Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
Hazard: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
Hazard: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Hazard: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Hazard: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of m
Hazard: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
Hazard: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medicatio
Hazard: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
July 3, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isol
Hazard: leaking pouches
July 3, 2013DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporatio
Hazard: Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
May 15, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Lue
Hazard: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
May 15, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Act
Hazard: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
May 15, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Ad
Hazard: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
May 15, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use o
Hazard: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.