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OnGuard Spike Port Adaptor
SIMPLIVIA HEALTHCARE LTD · Model 412113 · UDI-DI 37290115921138
ONB
Prescription
1
510(k) clearances
4,967
Adverse events
73
Recalls
42
Facilities
Description
The Spike Port Adaptor is part of the OnGuard CSTD system. The devices spike connects to IV solution container. The proximal end connects to IV set spike, to allow administration. The port connects to OnGuard2 Syringe Adaptor to transfer drug or withdraw saline / drug.
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.