Bd Switzerland Sarl: Stopcock, I.v. Set
BD Connecta BD Luer-Lok 360 stopcocks, which are IV devices used to deliver fluids, medications, and nutritional products, are being recalled because the connection port may over-thread or continue spinning instead of securing tightly when used with plastic syringes. This threading issue has caused some clinical users to be concerned about connection stability. The recall affects devices 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
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/65d6abfe-76bc-477c-8196-a68cfa6edeae