Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
FDA adverse event reports and recall history for closed antineoplastic and hazardous drug reconstitution and transfer system (product code ONB), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 4,967
- Deaths
- 0
- Injuries
- 151
- Malfunctions
- 4,788
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-11Open, ClassifiedProcess control
Oncology sets with drip chambers
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
- 2026-09-11Open, ClassifiedProcess control
IV Sets with drip chambers
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
- 2026-05-18Open, ClassifiedProcess control
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
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 occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
- 2025-10-27Open, ClassifiedUnder Investigation by firm
ChemoLock Bag Spike, 01 units REF: CL-10-10
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-10-27Open, ClassifiedUnder Investigation by firm
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-10-27Open, ClassifiedUnder Investigation by firm
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-10-27Open, ClassifiedUnder Investigation by firm
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-10-27Open, ClassifiedUnder Investigation by firm
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-10-27Open, ClassifiedUnder Investigation by firm
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- 2025-10-27Open, ClassifiedUnder Investigation by firm
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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