FDA Device Intelligence
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Set, I.V. Fluid Transfer

FDA product code LHI · Class 2 · General Hospital

931
Registered devices
14,331
Adverse events
61
Recalls
206
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-02-20Omnicell, Inc.IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intend
2024-09-24West Pharmaceutical Services AZ, Inc.Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
2024-08-20Baxter Healthcare CorporationBaxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Produ
2024-08-20Baxter Healthcare CorporationBaxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Produ
2024-08-20Baxter Healthcare CorporationBaxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Produ
2024-08-20Baxter Healthcare CorporationBaxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Produ
2023-12-22Baxter Healthcare CorporationAn error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This
2023-12-22Baxter Healthcare CorporationAn error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This
2022-09-16International Medical Industries, Inc.Blister package had an unsealed edge compromising sterility.
2022-07-14Baxter Healthcare CorporationThere is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.