# K071108: Texium Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Alaris Products
- Decided: May 24, 2007 after 35 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883614 (1988). 8 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053049: Alaris Safety Male Luer, Cardinal Health, Alaris Products (2006) Summary page 1.
- K954064: Becton Dickinson Syringse, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 2.

## Most influential descendants
- K083152: Equashield System (2009), 9 descendants of its own
- K091389: Equalshield Luer Lock Connector Pair (2009), 8 descendants of its own
- K101940: Equashield System Protective Plus (2010), 7 descendants of its own
- K132899: Equashield Closed System Drug Transfer Device (CSTD) (2014), 6 descendants of its own
- K170706: Equashield Closed System drug Transfer Device (CSTD) (2017), 5 descendants of its own

## Recalls of this device
- May 12, 2025 · Class II · Z-1971-2025: 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 connect

## Indications for use
The TexiumTM Syringe is indicated for use by healthcare professionals for fluid aspiration/injection, reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The TexiumTM Syringe is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.

Source page: https://510kreport.com/device/K071108
Methodology: https://510kreport.com/methodology