Recall Z-1509-2025— BD SWITZERLAND SARL

Name: FDA recall Z-1509-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-20

Class II · Ongoing

Class II FDA medical device recall by BD SWITZERLAND SARL, initiated 2025-02-20. It names one FDA 510(k) clearance: K974083. 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).

Recalling firm: BD SWITZERLAND SARL
Classification: Class II
Status: Ongoing
Initiated: 2025-02-20
Firm location: Eysins, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K974083 — CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKSOhmeda Medical·cleared 1998-01-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

Data sourced from openFDA. This site is unofficial and independent of the FDA.