Bd Switzerland Sarl: Bd Connecta" Bd Luer-lok" 360 Ref 394910 Udi-di Code: 00382903949106 Bd Connecta" Stopcocks Are Used To Administer Fluids Or Medication Through One...

Recall Summary BD Connecta BD Luer-Lok 360 stopcocks—devices used to deliver fluids and medications through IV lines—are being recalled because the connection at Port C may continue spinning rather than tightening securely when used with plastic luer-lok syringes. This defect has caused some clinical users to question whether the connection is stable. The recall affects units distributed across most U.S. states and Japan.

Recalling firm
BD SWITZERLAND SARL
Product
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.
Reason
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.
Classification
Class II
Category
medical device recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-05-21
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, FL, GA, IL, IN, IA, KS, ...
Distribution
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

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/715d349b-6831-44a0-b7bb-45c64e4f40b0