BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Summary
The FDA issued a Class II for BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), R by BD SWITZERLAND SARL. Reason: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the clos.
Details
Source
Device Recall
External ID
Z-1974-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Lot/Code Info: 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)
Quantity Affected: 1,006,512
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-12
Company
Eysins
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BD SWITZERLAND SARL has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BD SWITZERLAND SARL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BD SWITZERLAND SARL have FDA actions?
BD SWITZERLAND SARL has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1974-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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