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: 1,265,400 Lot/code info: UDI-DI/Lot(Expiration): MY8003/10885403221651/23125144(December 5, 2026), 24015468(January 20, 2027), 24025611(February 5, 2027), 24026390(February 27, 2027), 24036107(March 25, 2027), 24045647(April 24, 2027), 24055859(May 27, 2027), 24095513(September 24, 2027), 92217803(June 27, 2025), 92225801(September 15, 2025), 92231303(November 9, 2025), 92300201(January 2, 2026), 92308702(March 28, 2026), 92309501(April 5, 2026), 92313601(May 16, 2026), 92315701(June 6, 2026) MY8005/10885403221668/23125145(December 5, 2026), 24015467(January 20, 2027), 24026387(February 27, 2027), 24045646(April 24, 2027), 24055858(May 27, 2027), 24075164(July 26, 2027), 24095512(September 24, 2027), 92215201(June 1, 2025), 92220802(July 27, 2025), 92225502(September 12, 2025), 92315102(May 31, 2026); MY8010/10885403221675/24015312(January 15, 2027), 24025610(February 5, 2027), 24045645(April 24, 2027), 24055857(May 27, 2027), 24066953(June 25, 2027), 24075165(July 26, 2027), 24085486(August 26, 2027), 24095511(September 24, 2027), 24105167(October 25, 2027), 92218601(July 5, 2025), 92222902(August 17, 2025), 92223601(August 24, 2025), 92229201(October 19, 2025), 92230701(November 3, 2025), 92231301(November 9, 2025), 92231302(November 9, 2025), 92307402(March 15, 2026), 92311601(April 26, 2026), 92315101(May 31, 2026); MY8020/10885403221682/23115069(November 3, 2026), 24015311(January 15, 2027), 24025935(February 7, 2027), 24035566(March 5, 2027), 24036106(March 25, 2027), 24045644(April 24, 2027),
10885403221651, 10885403221668, 10885403221675, 10885403221682, 10885403230523, 10885403221699
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.