[pending] BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are
Pending LLM rewrite. Source: FDA_DEVICE Z-2514-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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.
- Manufacturer
- BD SWITZERLAND SARL
- Category
- Medical Device — Devices
Distribution
Distributed in 39 states:
- 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
- WV
Related recalls
Same category
- SevereMedline Convenience Kits with Swan-Ganz Catheters Recalled for Defects
FDA (Devices) · 2026-07-08
- HighDePuy Synthes ATTUNE Revision Hinge Knee Insert Components Recall
FDA (Devices) · 2026-07-08
- HighCRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08