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
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 19, 2010 | K090917 | SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM Baxa Corp. | LHI |
| Aug 3, 2007 | K070163 | SWABBABLE CAP, MODEL 60205 Baxa Corp. | ODI |
| Mar 9, 2007 | K062909 | REPEATER PUMP II TUBE SETS Baxa Corp. | FPA |
| Aug 12, 2002 | K022523 | RAPID-FILL TUBESET, MODEL 90005 Baxa Corp. | LHI |
| Mar 28, 2001 | K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 Baxa Corp. | LHI |
| Oct 6, 1998 | K983321 | MICROFUSE DUAL RATE INFUSER Baxa Corp. | FRN |
| Jun 21, 1995 | K951871 | PISTON SYRINGE Baxa Corp. | FMF |
| Feb 25, 1994 | K933506 | SYRINGE INFUSER Baxa Corp. | FRN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2013 | Baxa 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 |
LHI | K900585 |
| Jul 18, 2013 | Baxa Corporation ExactaMix 1200 and 2400 Compounders.
Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution. Terminated |
LHI | K002705 |
| Oct 25, 2012 | Baxa 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 |
NEP | None listed |
| May 25, 2012 | Baxa Corporation Abacus TPN Calculating Software
Product Usage:
LIMS Windows-based program for order entry and TPN calculation. Terminated |
LNX | None listed |
| Apr 13, 2012 | Baxa 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 |
LHI | K900585 |
| Apr 9, 2012 | Baxa 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 |
NEP | None listed |
| Apr 5, 2012 | Baxa 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 |
NEP | None listed |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Apr 12, 2011 | Baxa 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 |
LHI | K900585 |
| Aug 2, 2010 | Baxa 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 |
KPE | K900585 |
| Aug 2, 2010 | Baxa 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 |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724, Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341, Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation. Terminated |
KPE | K900585 |
| Mar 23, 2010 | Baxa 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 |
LHI | K002705 |
| Mar 9, 2010 | Baxa Corporation Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation Terminated |
KPE | K900585 |
| Mar 9, 2010 | Baxa Corporation Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation Terminated |
KPE | K900585 |
| Mar 9, 2010 | Baxa Corporation Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation. Terminated |
KPE | K900585 |
| Aug 19, 2008 | Baxa 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 |
NEP | None listed |
| Aug 19, 2008 | Baxa 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 |
NEP | None listed |
| Sep 27, 2007 | Baxa Corporation Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112. Terminated |
NEP | None listed |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Primary Valve Assembly Terminated |
LHI | K900585 |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Primary Valve Assembly, Pediatric Terminated |
LHI | K900585 |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Primary Valve Assembly Terminated |
LHI | K900585 |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Six Inlet, Tubing Kit Terminated |
LHI | K900585 |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled Terminated |
LHI | K900585 |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Secondary Valve Assembly Terminated |
LHI | K900585 |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube Terminated |
LHI | K900585 |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix 2400 pharmacy compounding system. Terminated |
NEP | K002705 |