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

This recall is currently active, issued June 12, 2025.

Recall Initiated: May 12, 2025
Posted: June 12, 2025
Recall Number: Z-1972-2025
Quantity: 812,165
Official Source: View on FDA website ↗

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.

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), 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);

Root Cause

Process control

Action Taken

On 5/12/2025, removal notices were mailed or emailed to Medical Director, Risk Manager, Medical Device Safety Officer, Nurse Managers, and Distributors who were asked to do the following: 1. Immediately review your inventory for affected product. Destroy all unused affected products subject to the recall following your institution s process for destruction. 2. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 3. Complete the Customer Response Form via email to bdrc53@bd.com 4. In addition, distributors were asked to identify all customers that purchased any affected product and to provide a copy of the customer letter to all customers and to advise them of the removal notification. Report any complaints experienced with the use of this product to the firm's North American Regional Complaint Center: Phone: 1-844-823-5433 Mon-Fri 8:00am and 5:00pm CT, Email: productcomplaints@bd.com