Home › SIMPLIVIA HEALTHCARE LTD › OnGuard2 Syringe Adaptor, 5 Units

OnGuard2 Syringe Adaptor, 5 Units

SIMPLIVIA HEALTHCARE LTD · Model 412188 · UDI-DI 27290115921889

ONB Prescription

510(k) clearances

4,967

Adverse events

Recalls

Facilities

Description

OnGuard2 Syringe Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to Chemfort port (e.g., Vial Adaptor) The device Proximal end is intended to connect to luer syringe

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.