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Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

FDA product code ONB · Class 2 · General Hospital

457
Registered devices
4,732
Adverse events
71
Recalls
41
510(k) clearances

Devices with this code

ICU Medical — ICU MEDICAL, INC.BD PhaSeal Optima — BD Switzerland SàrlICU Medical — ICU MEDICAL, INC.TEVADAPTOR® Syringe Adaptor — TEVA PHARMACEUTICAL INDUSTRIES LIMITEDICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.TEVADAPTOR® Connecting Set — TEVA PHARMACEUTICAL INDUSTRIES LIMITEDICU MEDICAL — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ProSeal CSTD — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDICU Medical — ICU MEDICAL, INC.Equashield — EQUASHIELD MEDICAL LTDBD PhaSeal Optima — BD Switzerland SàrlEquashield — EQUASHIELD MEDICAL LTDICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.BD PhaSeal — BD Switzerland SàrlICU Medical — ICU MEDICAL, INC.OnGuard®2 CSTD Bag Adaptor SP — SIMPLIVIA HEALTHCARE LTD

Recent recalls

DateFirmReason
2026-03-24ICU Medical, Inc.Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak oc
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.
2025-09-08ICU Medical, Inc.Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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