Recall Z-1974-2025
BD Switzerland Sarl · initiated May 12, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Codes / lots: REF/UDI-DI/Lot(Expiration): 10012241/07613203010450/23015679(January 31, 2026), 23035092(March 6, 2026), 23055076(May 4, 2026), 23075108(July 5, 2026), 23095125(September 8, 2026), 23105028(October 3, 2026), 23125147(December 5, 2026), 24015246(January 11, 2027), 24026422(February 27, 2027), 24036125(March 25, 2027), 24045689(April 24, 2027), 24066894(June 25, 2027), 24075112(July 26, 2027), 24095557(September 24, 2027), 24115004(November 1, 2027); 10012241 CHINA/10885403238383/23095707(September 14, 2026), 24025890(February 7, 2027), 24105002(October 3, 2027)
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.
FDA-determined 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
Details
- Recall number
- Z-1974-2025
- Initiated
- May 12, 2025
- Posted by FDA
- June 12, 2025
- Product code
- FPA – Set, Administration, Intravascular
- Quantity
- 1,006,512
- 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.
- Recalling firm
- BD Switzerland Sarl, Eysins
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1970-2025 Class II | Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap…Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes… | 05/12/2025Open, Classified |
| Z-1971-2025 Class II | BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010…Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes… | 05/12/2025Open, Classified |
| Z-1972-2025 Class II | BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20…Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes… | 05/12/2025Open, Classified |
| Z-1973-2025 Class II | BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes… | 05/12/2025Open, Classified |