47 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class II
·Terminated·Baxa Corporation·September 18, 2013
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 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 Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·July 9, 2014
Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers.
FDA Enforcement
Class II
·Terminated·Baxa Corporation·October 31, 2012
ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include: non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes
FDA Enforcement
Class II
·Terminated·Baxter Corporation Englewood·December 25, 2013
Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·November 12, 2009
Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·November 12, 2009
Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·November 12, 2009
Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile and non-pyrogenic in unopened, undamaged package, 250 mL, Order No. REF: 706D, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010
Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL, Order No. REF 706, Baxa Corporation.
FDA Recall
Terminated
·Baxa Corporation·Product code KPE·May 26, 2010