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.
Recall
- Recall Number
- Z-2514-2026
- Event Number
- 98855
- FEI Number
- 3012798826
- Product Code
- FMG
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- May 21, 2026
- Posted
- June 18, 2026
- Address
- BD SWITZERLAND SARL Terre Bonne Park A4 Route De Crassier 17 Eysins Switzerland
Description
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.
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: [email protected] 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: [email protected]
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
2,465,500 units