Class 2 Device Recall BD Connecta BD LuerLok 360

• Date Initiated by Firm: February 20, 2025
• Date Posted: April 02, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1509-2025
• Recall Event ID: 96399
• 510(K)Number: K974083
• Product Classification: Stopcock, i.V. Set - Product Code FMG
• 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.
• Code Information: Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700
• FEI Number: 3012798826
• Recalling Firm/ Manufacturer: BD SWITZERLAND SARL; Terre Bonne Park A4; Route De Crassier 17; Eysins Switzerland
• For Additional Information Contact: Krista DiPaula; 410-598-9328
• Manufacturer 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)
• FDA Determined Cause: Labeling Change Control
• Action: 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: productcomplaints@bd.com or bdrc55@bd.com
• Quantity in Commerce: 500 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMG