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Recall Observatory FDA recall evidence

Device product

BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500

Z-1973-2025

May 12, 2025

Class II

Product summary

Firm
BD SWITZERLAND SARL
Event
Event 96737
Status
Ongoing
Classification
Class II
Quantity
1,655,300
Official record key
device-enforcement:Z-1973-2025

Official wording

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.

Code information: REF/UDI-DI/Lot(Expiration): 10012241-0500/10885403221705/23045145(April 3, 2026), 23045146(April 3, 2026), 23055091(May 4, 2026), 23065090(June 3, 2026), 23075107(July 5, 2026), 23095124(September 8, 2026), 23105027(October 3, 2026), 23115047(November 2, 2026), 23125146(December 5, 2026), 24015245(January 11, 2027), 24025887(February 7, 2027), 24026421(February 27, 2027), 24036126(March 25, 2027), 24045690(April 24, 2027), 24066893(June 25, 2027), 24075111(July 26, 2027), 24095556(September 24, 2027), 24125014(December 2, 2027), 23035049(March 1, 2026)

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.