Recall Z-2453-2025 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
BD SWITZERLAND SARL
BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF: 515102 BD PhaSeal Protector (P21 Multi), REF: 515103 BD PhaSeal Protector (P28), REF: 515104 BD PhaSeal Protector (P50), REF:
| Date | Aug 27, 2025 (initiated Jun 16, 2025) |
| Status | Open, Classified |
| Reason | Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it. |
| Root cause | Error in labeling |
| Action | On 6/16/2025, Medical Device Product Advisory notices were mailed and emailed to customers who were asked to do the following: 1) The US IFU to be attached to your product can be accessed and downloaded from the following link by searching under the applicable product code: The US IFU to be attached to your product can be accessed and downloaded from the following link by searching under the applicable product code: eIFU.bd.com 2) Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred |
| Quantity | 3,884,670 |
| Distribution | US Nationwide distribution including in the states of CA, WA, AL, OH, NC, GA, MA, IL, MO, AZ, PA, MS, MN, MI, TX, VA, IN, NV, CO, FL, WV, WI, NY, NJ, UT, MD, MT, NM, TN, HI, OK, OR, AK, DC, IA, LA, ME, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123213 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE Becton, Dickinson & CO, Jan 9, 2013 |
| K130197 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 Becton, Dickinson and Company, Feb 27, 2013 |
| K140591 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR Becton, Dickinson & CO, May 14, 2014 |
| K181221 | BD PhaSeal Optima Closed System Transfer Device Becton, Dickinson and Company, Nov 30, 2018 |
| K201099 | BD PhaSeal Optima Closed System Drug Transfer Device Becton, Dickinson and Company, Aug 12, 2020 |