510(k) K900585 ยท LHI Set, I.V. Fluid Transfer
TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
| Applicant | Baxa Corp., Sub. of Cook Group, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Apr 18, 1990 |
| Received | Feb 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2019 | Baxter Healthcare Corporation 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, 3 Terminated |
LHI | None listed |
| Nov 2, 2018 | Baxter Healthcare Corporation EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Terminated |
KPE | None listed |
| Nov 2, 2018 | Baxter Healthcare Corporation EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Terminated |
KPE | None listed |
| Nov 2, 2018 | Baxter Healthcare Corporation EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Terminated |
KPE | None listed |
| Nov 2, 2018 | Baxter Healthcare Corporation EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Terminated |
KPE | None listed |
| Nov 2, 2018 | Baxter Healthcare Corporation EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. Terminated |
KPE | None listed |
| Oct 6, 2016 | Baxter Corporation Englewood 0.2 Micron Filter, 50 mm
Product Usage:
The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set. Terminated |
LHI | None listed |
| 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 | 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | None listed |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation. Terminated |
KPE | None listed |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation. Terminated |
KPE | None listed |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation. Terminated |
KPE | None listed |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation. Terminated |
KPE | None listed |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation. Terminated |
KPE | None listed |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation. Terminated |
KPE | None listed |
| Aug 2, 2010 | Baxa Corporation Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation. Terminated |
KPE | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Mar 9, 2010 | Baxa Corporation Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation. Terminated |
KPE | None listed |
| Mar 9, 2010 | Baxa Corporation Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation Terminated |
KPE | None listed |
| Mar 9, 2010 | Baxa Corporation Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation Terminated |
KPE | None listed |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube Terminated |
LHI | None listed |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Secondary Valve Assembly Terminated |
LHI | None listed |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled Terminated |
LHI | None listed |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Six Inlet, Tubing Kit Terminated |
LHI | None listed |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Primary Valve Assembly Terminated |
LHI | None listed |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Primary Valve Assembly, Pediatric Terminated |
LHI | None listed |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix Valve Set, Primary Valve Assembly Terminated |
LHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.