133 results
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32ms
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Sources: EU EUDAMED, US FDA
5 ML EXACTA MED ORAL LIQUID DISPENSER
FDA Adverse Event
Malfunction
·BAXA CORP·Product code LHI·April 30, 2010
EXACTA-MIX 2400, MAIN MODULE
FDA Adverse Event
Malfunction
·BAXA CORPORATION·Product code LHI·June 11, 2010
EXACTA-MIX EMPTY EVA CONTAINER
FDA Adverse Event
Malfunction
·BAXA CORPORATION·Product code LHI·May 12, 2010
EXACTA-MIX 2400
FDA Adverse Event
Other
·BAXA CORP.·Product code NEP·May 6, 2010
TPN PC PLUS
FDA Adverse Event
Injury
·BAXA CORP.·Product code LNX·October 28, 2003
EXACTA-MIX EMPTY EVA CONTAINER
FDA Adverse Event
Malfunction
·BAXA CORP.·Product code KPE·April 2, 2010
EXACTA-MED ORAL DISPENSERS 0.5ML/1ML/3ML/5ML
FDA Adverse Event
Malfunction
·BAXA CORPORATION·Product code KYX·February 7, 2007
TWO-FER NEEDLES
FDA Adverse Event
Malfunction
·BAXA CORP.·Product code LHI·August 17, 2009
EXACTA-MIX EMPTY EVA CONTAINER
FDA Adverse Event
Malfunction
·BAXA CORP.·Product code KPE·January 14, 2010
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, EVA CONTAINER, 3-LITER CAPACITY
FDA Adverse Event
Malfunction
·BAXA CORP.·Product code KPE·September 1, 2011
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 12, 2010
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 27, 2010
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 29, 2010
EM2400 VALVE SET
FDA Adverse Event
Malfunction
·BAXA CORP.·Product code LHI·February 26, 2009
MICROFUSE RAPID RATE INFUSER
FDA Adverse Event
Malfunction
·BAXA CORP.·Product code FRN·September 28, 2006
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·October 19, 2011
SIGMA
FDA Adverse Event
Malfunction
·SIGMA INTERNATIONAL·Product code FRN·November 10, 2004
SMARTSITE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·November 12, 2015
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