510(k) K123213 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
| Applicant | Becton, Dickinson & CO, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Jan 9, 2013 |
| Received | Oct 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2025 | 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: 51500 Open, Classified |
ONB | None listed |
| Jul 18, 2022 | Becton Dickinson & Company BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the es Open, Classified |
ONB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.