510(k) K002705 ยท LHI Set, I.V. Fluid Transfer
EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
| Applicant | Baxa Corp., Englewood CO, US |
| Decision | Substantially Equivalent, Mar 28, 2001 |
| Received | Aug 30, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2026 | Baxter Healthcare Corporation Brand Name: Exacta Mix
Product Name: Vented Micro-Volume Inlet
Model/Catalog Number: H938175
Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve Open, Classified |
NEP | None listed |
| Sep 19, 2024 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device Open, Classified |
LHI | None listed |
| Sep 19, 2024 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device Open, Classified |
LHI | None listed |
| Sep 19, 2024 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device Open, Classified |
LHI | None listed |
| Sep 19, 2024 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device Open, Classified |
LHI | None listed |
| Feb 16, 2024 | Baxter Healthcare Corporation Baxter Exactamix Pro 1200, REF EXM12DY Open, Classified |
LHI | None listed |
| Feb 16, 2024 | Baxter Healthcare Corporation Baxter Exactamix Pro 2400, REF EXM24DY Open, Classified |
LHI | None listed |
| Aug 24, 2022 | Baxter Healthcare Corporation The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. Thi Open, Classified |
LHI | None listed |
| Apr 25, 2018 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173
Product Usage:
Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the p Terminated |
LHI | None listed |
| Apr 25, 2018 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174
Usage:
Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to c Terminated |
LHI | None listed |
| Apr 25, 2018 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175
Usage:
Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to Terminated |
LHI | None listed |
| Apr 25, 2018 | Baxter Healthcare Corporation Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176
Usage:
Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound mult Terminated |
LHI | None listed |
| 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 | None listed |
| 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 | None listed |
| Jul 20, 2004 | Baxa Corporation Exacta-Mix 2400 pharmacy compounding system. Terminated |
NEP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.