Recall Z-1973-2025— BD SWITZERLAND SARL
Class II · Ongoing
Class II FDA medical device recall by BD SWITZERLAND SARL, initiated 2025-05-12. It names one FDA 510(k) clearance: K053049. Product: BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500. 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 recordK-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 CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
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.