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System/Device, Pharmacy Compounding

FDA product code NEP · Class 2 · General Hospital

167

Registered devices

1,226

Adverse events

Recalls

510(k) clearances

Devices with this code

DUO-VENT — Baxter Healthcare SA APEX™ — B. BRAUN MEDICAL INC.APOTECAsyringe — AEA SRL GRI-BAG — LABORATORIOS GRIFOLS SA DianaTM Compounding Workflow System — ICU MEDICAL, INC.DUAL LEAD HIGH VOLUME PUMP CHAMBER SET — MPS Pharma & Medical, Inc.PINNACLE® — B. BRAUN MEDICAL INC.ICU Medical, Inc. — ICU MEDICAL, INC.DianaTM Compounding Workflow System — ICU MEDICAL, INC.EXACTAMIX — BAXTER CORPORATION ENGLEWOOD ICU Medical, Inc. — ICU MEDICAL, INC.REPEATER — BAXTER HEALTHCARE CORPORATION APEX™ — B. BRAUN MEDICAL INC.NA — BAXTER HEALTHCARE CORPORATION PINNACLE® — B. BRAUN MEDICAL INC.EXACTAMIX — BAXTER HEALTHCARE CORPORATION IVX Cloud — Omnicell, Inc.DianaTM Compounding Workflow System — ICU MEDICAL, INC.APEX® — B. BRAUN MEDICAL INC.GRI-FILL — LABORATORIOS GRIFOLS SA GRI-BAG — LABORATORIOS GRIFOLS SA Silicon Tubing Set — Xvivo Perfusion AB ICU Medical, Inc — ICU MEDICAL, INC.REPEATER — BAXTER HEALTHCARE CORPORATION

Recent recalls

Date	Firm	Reason
2026-04-22	Baxter Healthcare Corporation	Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency
2026-03-25	Omnicell, Inc.	Potential for mislabeled syringe produced by the i.v.STATION device.
2023-03-27	OmniCell, Inc.	IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy state
2022-06-22	Baxter Healthcare Corporation	There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
2021-03-31	Smiths Medical ASD Inc.	Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or
2021-03-31	Smiths Medical ASD Inc.	Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or
2020-11-23	B Braun Medical, Inc.	There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the o
2020-11-23	B Braun Medical, Inc.	There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the o
2020-11-23	B Braun Medical, Inc.	There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the o
2018-06-04	B. Braun Medical, Inc.	There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on

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