TEXIUM SYRINGE— 510(k) K071108

Clearance details

Applicant

Cardinal Health, Alaris Products

Product code

Code FMF

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2007-04-19

Decision date

2007-05-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

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• K071400 — SMARTSITE STOPCOCK2007-12-14
• K061285 — SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS2006-07-26
• K053049 — ALARIS SAFETY MALE LUER2006-01-12
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Death

15

Injury

2,263

Malfunction

29,722

Other

17

Total

32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1971-2025 — BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060Class II·Ongoing·BD SWITZERLAND SARL·20250512

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071108.