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: 2,024,780 Lot/code info: REF/UDI-DI/Lot(Expiration): 10013361T/10885403223204/23025303(February 10, 2026), 23035235(March 11, 2026), 23045223(April 6, 2026), 23075395(July 17, 2026), 23085227(August 8, 2026), 23115150(November 8, 2026), 23115151(November 8, 2026), 23125167(December 5, 2026), 24025684(February 6, 2027), 24045377(April 23, 2027), 24055576(May 27, 2027), 24075224(July 26, 2027), 24105079(October 11, 2027), 24115159(November 7, 2027); 10321213T/10885403228971/23035169(March 15, 2026), 23045174(April 4, 2026), 23085140(August 3, 2026), 23095142(September 11, 2026), 23105297(October 12, 2026), 24025686(February 6, 2027); 22000-B007T/10885403245022/23025320(February 13, 2026), 23045224(April 11, 2026), 23065209(June 10, 2026), 23075394(July 21, 2026), 23095143(September 11, 2026), 23105133(October 6, 2026), 24015278(January 13, 2027), 24025685(February 6, 2027), 24036209(March 25, 2027), 24075260(July 26, 2027), 24066653(June 24, 2027); 22600-0007T/10885403239595/23095151(September 11, 2026), 24036205(March 25, 2027), 24055601(May 27, 2027); 22602-B007T/10885403240935/23045501(April 20, 2026), 23095152(September 11, 2026), 24015186(January 9, 2027), 24026152(February 27, 2027), 24036206(March 25, 2027), 24045384(April 23, 2027), 24115032(November 2, 2027); 22603-B007T/10885403240942/23035482(March 23, 2026), 23035504(March 25, 2026), 23055379(May 23, 2026), 23065210(June 12, 2026), 23075056(July 13, 2026), 23085141(August 3, 2026), 23095808(September 14, 2026), 23105296(October 12, 2026), 2
10885403223204, 10885403228971, 10885403245022, 10885403239595, 10885403240935, 10885403240942, 10885403271021, 10885403223198, 10885403240959, 10885403240997, 10885403229756, 10885403225628, 10885403198915, 10885403240867, 10885403250781
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.