ClearanceBrief
510(k) K900585 ยท LHI Set, I.V. Fluid Transfer

TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP

ApplicantBaxa Corp., Sub. of Cook Group, Inc., Englewood CO, US
DecisionSubstantially Equivalent, Apr 18, 1990
ReceivedFeb 7, 1990
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K900585

DateFirm and productCodeLinked 510(k)
Sep 18, 2019Baxter 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
LHINone listed
Nov 2, 2018Baxter 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
KPENone listed
Nov 2, 2018Baxter 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
KPENone listed
Nov 2, 2018Baxter 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
KPENone listed
Nov 2, 2018Baxter 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
KPENone listed
Nov 2, 2018Baxter 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
KPENone listed
Oct 6, 2016Baxter 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
LHINone listed
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
LHINone 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
LHINone listed
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
LHINone listed
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
LHINone listed
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
LHINone listed
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
LHINone listed
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
LHINone 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
LHINone listed
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.
Terminated
KPENone listed
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation.
Terminated
KPENone listed
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation.
Terminated
KPENone listed
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation.
Terminated
KPENone listed
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation.
Terminated
KPENone listed
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.
Terminated
KPENone listed
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation.
Terminated
KPENone listed
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
KPENone listed
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
KPENone listed
Aug 2, 2010Baxa Corporation
Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724, Baxa Corporation.
Terminated
KPENone listed
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
KPENone listed
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
KPENone listed
Mar 9, 2010Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
Terminated
KPENone listed
Mar 9, 2010Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation
Terminated
KPENone listed
Mar 9, 2010Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation
Terminated
KPENone listed
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Primary Valve with Detachable Pump Tube
Terminated
LHINone listed
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Secondary Valve Assembly
Terminated
LHINone listed
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled
Terminated
LHINone listed
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Six Inlet, Tubing Kit
Terminated
LHINone listed
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Primary Valve Assembly
Terminated
LHINone listed
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Primary Valve Assembly, Pediatric
Terminated
LHINone listed
Jul 20, 2004Baxa Corporation
Exacta-Mix Valve Set, Primary Valve Assembly
Terminated
LHINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.