510(k) K053049 ยท FPA Set, Administration, Intravascular
ALARIS SAFETY MALE LUER
| Applicant | Cardinal Health, Alaris Products, San Diego CA, US |
| Decision | Substantially Equivalent, Jan 12, 2006 |
| Received | Oct 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053049
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2025 | BD SWITZERLAND SARL Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T;
SmartSite Bag Access Non-Vented Bonded Texium Closed Ma Open, Classified |
FPA | None listed |
| Jun 12, 2025 | BD SWITZERLAND SARL BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 Open, Classified |
FPA | None listed |
| Nov 8, 2007 | Cardinal Health 303 Inc DBA Alaris Products Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.