FDA Medical Device Recalls (openFDA)
BD SWITZERLAND SARL: BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
- Recall number
- Z-1973-2025
- Recalling firm
- BD SWITZERLAND SARL
- Product
- BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
- Status
- Open, Classified
- Initiated
- 2025-05-12
- Posted
- 2025-06-12
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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
- Quantity
- 1,655,300
- 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, serial or model codes
- REF/UDI-DI/Lot(Expiration): 10012241-0500/10885403221705/23045145(April 3, 2026), 23045146(April 3, 2026), 23055091(May 4, 2026), 23065090(June 3, 2026), 23075107(July 5, 2026), 23095124(September 8, 2026), 23105027(October 3, 2026), 23115047(November 2, 2026), 23125146(December 5, 2026), 24015245(January 11, 2027), 24025887(February 7, 2027), 24026421(February 27, 2027), 24036126(March 25, 2027), 24045690(April 24, 2027), 24066893(June 25, 2027), 24075111(July 26, 2027), 24095556(September 24, 2027), 24125014(December 2, 2027), 23035049(March 1, 2026)
- 510(k) numbers
- ["K053049"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3012798826
- Firm city
- Eysins
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28