Z-1972-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 812,165
Product Description
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
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 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.
Code Information
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), 24026385(February 27, 2027), 24036110(March 25, 2027), 24045649(April 24, 2027), 24055853(May 27, 2027), 24066954(June 25, 2027), 24075168(July 26, 2027), 24085487(August 26, 2027), 24095515(September 24, 2027), 92221501(August 3, 2025), 92221503(August 3, 2025), 92222904(August 17, 2025), 92228502(October 12, 2025), 92228701(October 14, 2025), 92228702(October 14, 2025), 92229202(October 19, 2025), 92234001(December 6, 2025), 92301701(January 17, 2026), 92301702(January 17, 2026), 92302401(January 24, 2026), 92307401(March 15, 2026), 92310902(April 19, 2026); MY8030-0006/7613203026093/24025881(February 7, 2027), 24026384(February 27, 2027), 24036109(March 25, 2027), 24045648(April 24, 2027), 24066955(June 25, 2027), 24075167(July 26, 2027), 92215802(June 7, 2025), 92219201(July 11, 2025), 92220701(July 26, 2025), 92220801(July 27, 2025), 92225802(September 15, 2025), 92226501(September 22, 2025), 92231902(November 15, 2025); MY8060-0006/7613203018869/23125068(December 2, 2026), 24026383(February 27, 2027), 24045653(April 24, 2027), 24066879(June 24, 2027), 24075001(July 1, 2027), 24085489(August 26, 2027), 24095516(September 24, 2027), 24115310(November 5, 2027), 92218602(July 5, 2025), 92222001(August 8, 2025), 92223602(August 24, 2025), 92224302(August 31, 2025), 92225803(September 15, 2025), 92227002(September 27, 2025), 92227001(September 27, 2025), 92227901(October 6, 2025), 92233601(December 2, 2025), 92310102(April 11, 2026), 92310901(April 19, 2026);