Z-1973-2025Class II

Bd Texium Closed Male Luer with Female Cap, Ref: 10012241-0500

Name: Z-1973-2025 Bd Texium Closed Male Luer with Female Cap, Ref: 10012241-0500
Creator: Bd Switzerland Sarl
Published: 2025-05-12
License: https://open.fda.gov/license/

BD Switzerland SARL / initiated 2025-05-12 / Open, Classified / root cause: manufacturing process

FDA source

BD SWITZERLAND SARL began a recall of BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 on 2025-05-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1973-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-12
Posted: 2025-06-12
Recalling firm: BD Switzerland SARL
Product: Bd Texium Closed Male Luer with Female Cap, Ref: 10012241-0500
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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: [email protected]
Quantity in commerce: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1973-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1970-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12
Z-1971-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12
Z-1972-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12
Z-1973-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12
Z-1974-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12

Product code FPA

K053049Class IIAlaris Safety Male LuerCardinal Health, Alaris Products / cleared 2006-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)