TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP— 510(k) K900585

Clearance details

Applicant

Baxa Corp., Sub. of Cook Group, Inc.

Product code

Code LHI

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1990-02-07

Decision date

1990-04-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Englewood, CO, US

• K252987 — ADRx Admixture Device2026-06-12
• K260301 — Vial Adapter2026-06-05
• K250345 — Medline Bag Decanter2025-10-24
• K251715 — FlowArt® Vial Access Device Vented2025-10-14
• K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S) +3 more2025-09-16

• K910257 — BAXA PCA INFUSOR1991-11-07
• K903159 — VALVE CONTROLLER FOR MICROMACRO COMPOUNDER1990-11-07
• K904225 — KWIKMIX1990-11-05
• K873875 — BAXA EXACTA-MED PHARMACY PUMP1987-11-24
• K872743 — BAXA TUBING SETS (FOR PHARMACY PUMP)1987-10-09

Injury

207

Malfunction

7,820

Other

3

Total

8,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0167-2020 — 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, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.Class II·Terminated·Baxter Healthcare Corporation·20190918
• Z-0363-2019 — 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.Class II·Terminated·Baxter Healthcare Corporation·20180912
• Z-0364-2019 — 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.Class II·Terminated·Baxter Healthcare Corporation·20180912
• Z-0365-2019 — 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.Class II·Terminated·Baxter Healthcare Corporation·20180912
• Z-0366-2019 — 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.Class II·Terminated·Baxter Healthcare Corporation·20180912
• Z-0367-2019 — 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.Class II·Terminated·Baxter Healthcare Corporation·20180912
• Z-0007-2017 — 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.Class I·Terminated·Baxter Corporation Englewood·20160824
• Z-2165-2013 — 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.Class II·Terminated·Baxa Corporation·20130822

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K900585.