Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-

FDA device recall Z-1970-2025 · posted 2025-06-12 · Open, Classified

Recall details

Recalling firm

BD SWITZERLAND SARL

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.

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

FPA

Quantity affected

2,024,780

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

Date initiated

2025-05-12

Date posted

2025-06-12

Location

Eysins, Switzerland

Related 510(k) clearances