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OnGaurd2 CSTD Catheter Adaptor

SIMPLIVIA HEALTHCARE LTD · Model 412182 · UDI-DI 27290115921827

ONB Prescription

510(k) clearances

4,967

Adverse events

Recalls

Facilities

Description

The product is part of OnGuard2 Chemfort system for use with Chemfort / OnGuard2 CSTD Syringe Adaptor / Syringe Adaptor Lock The distal end of the Catheter Adaptor connect to a urinary catheter The proximal end of e Catheter Adaptor connects to Syringe Adaptor / Syringe Adaptor Lock

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 (PVC) material with
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 (PVC) material with
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 occurs during therapy
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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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.