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Catheter Adaptor

SIMPLIVIA HEALTHCARE LTD · Model MG412181 · UDI-DI 37290115921817

ONB Prescription
1
510(k) clearances
4,837
Adverse events
73
Recalls
41
Facilities

Description

The Catheter Adaptor distal end is attached to a tube The Catheter Adaptor proximal end is attached to OnGuard / OnGuard2 Syringe Adaptor or Syringe Adaptor Lock

Recalls

DateFirmReason
2026-05-12ICU Medical, Inc.Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2026-05-12ICU Medical, Inc.Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
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 occurs during therapy
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.