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OnGuard Luer Lock Adaptor
SIMPLIVIA HEALTHCARE LTD · Model 412114 · UDI-DI 27290115921148
ONB
Prescription
1
510(k) clearances
4,967
Adverse events
73
Recalls
42
Facilities
Description
The Luer Lock Adaptor is part of the OnGuard CSTD system. The proximal end connects to female luer lock of the IV set. The OnGuard2 Syringe Adaptor / Lock connects to the Lusr Lock Adaptor port
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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Get your free API keyRead the docsData 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.