FDA-Device2026-06-24Class IIPROCESSING DEFECT
BD Connecta BD Luer-Lok 360 stopcock recalled for loose Port C connection
BD Connecta stopcock recalled for loose connection risk
BD Connecta BD Luer-Lok 360 stopcocks used to administer IV fluids and medications may have a connection problem at Port C. When a plastic luer-lok syringe is attached, the connection may over-thread or continue spinning instead of tightening securely, making it feel unstable.
- Check your stopcocks against the affected lot numbers listed in the recall notice.
- If you have an affected stopcock, stop using it and contact BD or your healthcare facility for a replacement.
- Report any connection problems or patient incidents to BD and the FDA.
Hazard
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.
Sold states
U.S.: AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Japan
Affected count
2,465,500 units
Manufactured in
Terre Bonne Park A4, Route De Crassier 17, Eysins, Switzerland
Products
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2514-2026Don't want to check this manually?
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