Recall Z-1509-2025 ยท FMG Stopcock, I.V. Set
BD SWITZERLAND SARL
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.
| Date | Apr 2, 2025 (initiated Feb 20, 2025) |
| Status | Open, Classified |
| Reason | Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU) |
| Root 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 IF |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS Ohmeda Medical, Jan 13, 1998 |