BD Connecta BD Luer-Lok 360, REF 394910 recallZ-1509-2025 · Bd Switzerland Sarl · initiated Feb 20, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bd Switzerland Sarl or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
FDA root cause category: Labeling Change Control
What the company is doing
On 02/20/2025, the firm sent via FedEx and/or email an "URGENT: Medical Device Product Recall MDS-25-5241" letter informing customers that BD confirmed that specific lots of BD Connecta BD Luer-Lok 360 were shipped to the U.S. market with Instruction for Use (IFU) labeling meant for Outside U.S. market. Customers are instructed to: 1. Locate any unused affected BD Connecta" BD Luer-Lok" 360, as listed in Table 1. 2. Remove the IFU from each shelf-box and destroy it. (OUS IFU version, Document number 500037734). 3. Insert a copy of Attachment 1 BD Connecta IFU Document Number: 500081278 (US IFU version). 4. Circulate this notice to all those who need to be aware within their organization or to any organization where the potentially affected products have been transferred. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not customers have any of the impacted material so that BD may acknowledge their receipt of this notification. Report any questions or complaints experienced with the use of this product to BD via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT Email: [email protected] or [email protected]
Recall details
- Recall number
- Z-1509-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 20, 2025
- Posted by the FDA
- Apr 2, 2025
- Recalling firm
- Bd Switzerland Sarl
- Quantity
- 500 units
- Product code
- FMG
- FDA submissions
- K974083
- Distribution
- U.S.: 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 O.U.S.: N/A
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.
Code information (models, lots, serial numbers)
Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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