FDA recall Z-1973-2025

BD SWITZERLAND SARL · Class II · device

Product

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.

Distribution

Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.

Key facts

Status
Ongoing
Initiation date
2025-05-12
Report date
2025-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Eysins, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1973-2025