Alaris recallZ-1973-2025 · Bd Switzerland Sarl · initiated May 12, 2025

Why it was recalled

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 root cause category: Process control

What the company is doing

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]

Recall details

Recall number

Z-1973-2025

Recall class

Class II

Status

Open, Classified

Initiated by the company

May 12, 2025

Posted by the FDA

Jun 12, 2025

Recalling firm

Bd Switzerland Sarl

Quantity

1,655,300

Product code

FPA

FDA submissions

K053049

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 description

BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Alaris 10012241-0500

  BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall138 reports

Product lines

• AlarisBD Switzerland Sàrl · 85 models · 2,797 reports · 10 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 96737).

• Z-1970-2025 · Open, Classified
  Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bon…
• Z-1971-2025 · Open, Classified
  BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060