BD recalls Connecta Luer-Lok 360 and Plus models with specific lot numbers due to outside US instructions that could lead to IV therapy errors.
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
BD is recalling certain Connecta Luer-Lok 360 and Plus models because they were shipped with instructions for use outside the U.S. These instructions may cause errors in IV therapy. Affected users should check their product's lot numbers and contact BD for guidance.
The devices were shipped with instructions for use outside the U.S. that may not be appropriate for U.S. medical practices. This could lead to errors in IV therapy procedures if the instructions are followed incorrectly.
Users of BD Connecta Luer-Lok 360 and Plus models in the U.S. market with specific lot numbers are affected. Healthcare professionals using these devices for IV therapy are most at risk.
Check the product's lot numbers: 4277968, 4277973, 4282451, 4282461, 4289801, 4290582, 4292904, 4295848, 4305108, or 4306700. The UDI-DI code is 00382903949106 for these specific models.
Identify the lot numbers on your BD Connecta Luer-Lok 360 or Plus model to see if they match the affected lots listed.
Reach out to BD directly to confirm if your device is affected and get instructions on next steps.
BD Connecta Luer-Lok 360, Connecta Plus 1, and Connecta Plus 3 2-way and 3-way Stopcocks with lot numbers 4277968, 4277973, 4282451, 4282461, 4289801, 4290582, 4292904, 4295848, 4305108, or 4306700.
The devices were shipped with instructions for use outside the U.S. that may not be appropriate for U.S. medical practices, potentially leading to IV therapy errors.
No, the recall does not require immediate discontinuation. Affected users should check their lot numbers and contact BD for guidance.
We’ve drafted a message you can send BD to request your refund or repair — edit it as you like.
Subject: Recall Z-1509-2025 — BD BD Hello, I own a BD that is covered by recall Z-1509-2025 from BD. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
