[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
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