ClearanceBrief
Company ยท US

Baxa Corporation

FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2010. Name variants (Inc, Corp, punctuation) are merged.

8510(k) clearances (0 in 12 months)
40recalls (0 in 12 months)
33recalls that name a 510(k)

Product codes

CodeDeviceRecords
LHISet, I.V. Fluid Transfer20
KPEContainer, I.V.15
NEPSystem/Device, Pharmacy Compounding7
FRNPump, Infusion2
FMFSyringe, Piston1
FPASet, Administration, Intravascular1
LNX1
ODIAdministration Set Docking Station1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 19, 2010K090917SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
Baxa Corp.
LHI
Aug 3, 2007K070163SWABBABLE CAP, MODEL 60205
Baxa Corp.
ODI
Mar 9, 2007K062909REPEATER PUMP II TUBE SETS
Baxa Corp.
FPA
Aug 12, 2002K022523RAPID-FILL TUBESET, MODEL 90005
Baxa Corp.
LHI
Mar 28, 2001K002705EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
Baxa Corp.
LHI
Oct 6, 1998K983321MICROFUSE DUAL RATE INFUSER
Baxa Corp.
FRN
Jun 21, 1995K951871PISTON SYRINGE
Baxa Corp.
FMF
Feb 25, 1994K933506SYRINGE INFUSER
Baxa Corp.
FRN

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 6, 2013Baxa Corporation
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.
Terminated
LHIK900585
Jul 18, 2013Baxa Corporation
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Terminated
LHIK002705
Oct 25, 2012Baxa Corporation
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 Tri
Terminated
NEPNone listed
May 25, 2012Baxa Corporation
Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.
Terminated
LNXNone listed
Apr 13, 2012Baxa Corporation
Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.
Terminated
LHIK900585
Apr 9, 2012Baxa Corporation
Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding Sy
Terminated
NEPNone listed
Apr 5, 2012Baxa Corporation
The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. Pharmacy compounding system for mixing ingredients for intrava
Terminated
NEPNone listed
Apr 12, 2011Baxa Corporation
ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through a
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
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 a
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
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 a
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
ExactaMix EVA Container, 500mL, REF: 738, 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
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
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
Terminated
LHIK900585
Apr 12, 2011Baxa Corporation
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 t
Terminated
LHIK900585
Aug 2, 2010Baxa Corporation
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.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
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.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.
Terminated
KPEK900585
Mar 23, 2010Baxa Corporation
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 ingredi
Terminated
LHIK002705
Mar 9, 2010Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation
Terminated
KPEK900585
Mar 9, 2010Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation
Terminated
KPEK900585
Mar 9, 2010Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
Terminated
KPEK900585
Aug 19, 2008Baxa Corporation
Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.
Terminated
NEPNone listed
Aug 19, 2008Baxa Corporation
Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.
Terminated
NEPNone listed
Sep 27, 2007Baxa Corporation
Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
Terminated
NEPNone listed
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Primary Valve Assembly
Terminated
LHIK900585
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Primary Valve Assembly, Pediatric
Terminated
LHIK900585
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Primary Valve Assembly
Terminated
LHIK900585
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Six Inlet, Tubing Kit
Terminated
LHIK900585
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled
Terminated
LHIK900585
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Secondary Valve Assembly
Terminated
LHIK900585
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube
Terminated
LHIK900585
Jul 20, 2004Baxa Corporation
Exacta-Mix 2400 pharmacy compounding system.
Terminated
NEPK002705
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