126 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code LHI·June 10, 2014
B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4 bags per shipping box) Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
FDA Recall
Terminated
·B. Braun Medical Inc·Product code LHI·June 24, 2010
ExactaMix EVA Container, 250mL, REF: 737, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set
FDA Recall
Terminated
·Baxa Corporation·Product code LHI·March 8, 2011
ExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set
FDA Recall
Terminated
·Baxa Corporation·Product code LHI·March 8, 2011
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Recall
Terminated
·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018
Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code LHI·December 20, 2004
Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube
FDA Recall
Terminated
·Baxa Corporation·Product code LHI·April 30, 2004
AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code LHI·January 27, 2011
ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set
FDA Recall
Terminated
·Baxa Corporation·Product code LHI·March 8, 2011
Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code LHI·April 14, 2016
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code LHI·April 25, 2018
Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding, used to connect up to 24 source ingredients.
FDA Recall
Terminated
·Baxa Corporation·Product code LHI·February 10, 2010
ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set
FDA Recall
Terminated
·Baxa Corporation·Product code LHI·March 8, 2011
Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code LHI·April 25, 2018
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code LHI·September 18, 2019
Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code LHI·March 28, 2008
Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code LHI·April 25, 2018
Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code LHI·April 25, 2018
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
FDA Recall
Terminated
·Baxa Corporation·Product code LHI·June 4, 2013
Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.
FDA Recall
Terminated
·Baxa Corporation·Product code LHI·August 22, 2013