Texium Syringe

• • Ongoing Z-1971-2025 FDA Class II ·initiated 12 May 2025

  Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

510(k) Number

K071108 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Cardinal Health, Alaris Products →