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.
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. Quantity: 1,655,300 Lot/code info: 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)
10885403221705
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.