BD SWITZERLAND SARL recalls BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" S…

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

On 05/21/2026, the firm sent via email and FedEx an "URGENT: Medical Device Correction" Letter informing customers that, BD has identified an observed issue in how Port C of the BD Connecta Stopcocks operates during use. Reports received indicate that when using polypropylene plastic luer lock syringes, the connection at Port C may over thread the syringe and continue to spin. This behavior has led some clinical users to perceive the connection as unstable. Actions for Clinical Users: -Per current Instructions for Use: "Do not overtighten connections. Note: Resistance between the male luer connector and the BD Connecta Stopcock when rotating indicates the connection is fully engaged and secure. Instruction to follow: 1.Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 2.Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 3.Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 4.Report any 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 For Questions: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com

• FDA enforcement recordOfficial FDA database entry for Z-2514-2026
• 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.