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