Recall Z-1971-2025— BD SWITZERLAND SARL

Name: FDA recall Z-1971-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-12

Class II · Ongoing

Class II FDA medical device recall by BD SWITZERLAND SARL, initiated 2025-05-12. It names one FDA 510(k) clearance: K071108. Product: 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: MY8060. Reason: 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..

Recalling firm: BD SWITZERLAND SARL
Classification: Class II
Status: Ongoing
Initiated: 2025-05-12
Firm location: Eysins, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K071108 — TEXIUM SYRINGECardinal Health, Alaris Products·cleared 2007-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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: MY8060

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.