Home › Device types › ONB
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
FDA product code ONB · Class 2 · General Hospital
458
Registered devices
4,967
Adverse events
73
Recalls
41
510(k) clearances
Devices with this code
BD PhaSeal — BD Switzerland SàrlBD PhaSeal — BD Switzerland SàrlICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.Halo — J & J SOLUTIONS, INC.ICU Medical — ICU MEDICAL, INC.Equashield — EQUASHIELD MEDICAL LTDICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU 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.Catheter Adaptor — SIMPLIVIA HEALTHCARE LTDICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.Equashield — EQUASHIELD MEDICAL LTDICU Medical — ICU MEDICAL, INC.Equashield — EQUASHIELD MEDICAL LTDICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-12 | ICU Medical, Inc. | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride |
| 2026-05-12 | ICU Medical, Inc. | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride |
| 2026-03-24 | ICU 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 |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
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