510(k) K022209 ยท FPA Set, Administration, Intravascular
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
| Applicant | Alaris Medical Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 6, 2002 |
| Received | Jul 8, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | BD SWITZERLAND SARL BD Alaris Pump Infusion Sets
10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites
10015861A 10885403232626 50885403232624 BD Ala Open, Classified |
FPA | None listed |
| Oct 8, 2025 | CareFusion 303, Inc. BD Alaris Pump Infusion Sets for the following reference numbers:
C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site
10015414, 180 Micron Filter
2447-0007, Ball Valve Smar Open, Classified |
FPA | None listed |
| Aug 6, 2025 | CareFusion 303, Inc. BD Alaris Pump Infusion Sets
REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;
REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Val Open, Classified |
FRN | None listed |
| May 31, 2024 | BD SWITZERLAND SARL Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072
Tubing set used for delivery of fluids, medication, blood and blood products. Open, Classified |
FPA | None listed |
| Nov 17, 2023 | Becton Dickinson & Company BD Alaris Pump infusion sets (Product Name, Catalog #)
BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483;
BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Open, Classified |
FPA | None listed |
| Nov 17, 2023 | Becton Dickinson & Company BD gravity sets (Product Name, Catalog #)
32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER Open, Classified |
FPA | None listed |
| Nov 17, 2023 | Becton Dickinson & Company BD Extension Sets (Product Name, Catalog #)
BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902
BD EXTEN Open, Classified |
FPA | None listed |
| Sep 19, 2006 | Cardinal Health 303 Inc DBA Alaris Products Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232 Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.