BD SWITZERLAND SARL recalls BD Connecta BD Luer-Lok 360

Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

On 02/20/2025, the firm sent via FedEx and/or email an "URGENT: Medical Device Product Recall MDS-25-5241" letter informing customers that BD confirmed that specific lots of BD Connecta BD Luer-Lok 360 were shipped to the U.S. market with Instruction for Use (IFU) labeling meant for Outside U.S. market. Customers are instructed to: 1. Locate any unused affected BD Connecta" BD Luer-Lok" 360, as listed in Table 1. 2. Remove the IFU from each shelf-box and destroy it. (OUS IFU version, Document number 500037734). 3. Insert a copy of Attachment 1 BD Connecta IFU Document Number: 500081278 (US IFU version). 4. Circulate this notice to all those who need to be aware within their organization or to any organization where the potentially affected products have been transferred. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not customers have any of the impacted material so that BD may acknowledge their receipt of this notification. Report any questions or complaints experienced with the use of this product to BD via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT Email: productcomplaints@bd.com or bdrc55@bd.com

• FDA enforcement recordOfficial FDA database entry for Z-1509-2025
• FDA 510(k) clearance · K974083The device's official FDA premarket clearance record
• FDA device classification · FMGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find BD SWITZERLAND SARLSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.