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U.S. Department of Health and Human Services

Class 2 Device Recall Texium CSTD

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 Class 2 Device Recall Texium CSTDsee related information
Date Initiated by FirmMay 12, 2025
Date PostedJune 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1974-2025
Recall Event ID 96737
Product Classification Set, administration, intravascular - Product Code FPA
ProductBD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Code Information 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)
FEI Number 3012798826
Recalling Firm/
Manufacturer		 BD SWITZERLAND SARL
Terre Bonne Park A4
Route De Crassier 17
Eysins Switzerland
Manufacturer 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 2		Process control
ActionOn 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
Quantity in Commerce1,006,512
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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