FDA Device recall Z-1509-2025
BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are con…
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are con… by Bd Switzerland Sarl, citing due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1509-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-20 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Bd Switzerland Sarl |
| Distribution | AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV |
Product
BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.
Reason
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
Identifiers
| code_info | Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1509-2025%22
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