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: 812,165 Lot/code info: REF/UDI-DI/Lot(Expiration): MY8003-0006/7613203018821/24015489(January 22, 2027), 24025879(February 7, 2027), 24045651(April 24, 2027), 24055852(May 27, 2027), 24066957(June 25, 2027), 24075170(July 26, 2027), 24095519(September 24, 2027), 92215801(June 7, 2025), 92217802(June 27, 2025), 92220702(July 26, 2025), 92221502(August 3, 2025), 92303201(February 1, 2026), 92303202(February 1, 2026), 92312301(May 3, 2026), 92316401(June 13, 2026); MY8005-0006/7613203018838/24025878(February 7, 2027), 24026382(February 27, 2027), 24036112(March 25, 2027), 24045650(April 24, 2027), 24055851(May 27, 2027), 24066956(June 25, 2027), 24075169(July 26, 2027), 24095517(September 24, 2027), 92229203(October 19, 2025), 92229204(October 19, 2025), 92229701(October 24, 2025), 92230602(November 2, 2025), 92304101(February 10, 2026), 92308703(March 28, 2026), 92314401(May 24, 2026), 92314402(May 24, 2026); MY8010-0006/7613203018845/24025880(February 7, 2027), 24036111(March 25, 2027), 24045652(April 24, 2027), 24066958(June 25, 2027), 24075171(July 26, 2027), 24085488(August 26, 2027), 24095518(September 24, 2027), 24105168(October 25, 2027), 92217101(June 20, 2025), 92222903(August 17, 2025), 92233202(November 28, 2025), 92233201(November 28, 2025), 92300204(January 2, 2026), 92300901(January 9, 2026), 92301901(January 19, 2026), 92301902(January 19, 2026), 92303203(February 1, 2026), 92314403(May 24, 2026); MY8020-0006/7613203018852/24025882(February 7, 2027), 24025883(February 7, 2027), 2402638
7613203018821, 7613203018838, 7613203018845, 7613203018852, 7613203026093, 7613203018869
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.