BD Connecta Luer-Lok (Unknown) – Instruction Mismatch (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700
A medical device manufacturer is recalling BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta Plus 1 and Connecta Pl due to Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, FL, GA, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NM, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV
Page updated: Jan 10, 2026