510(k) K133532 ยท FRN Pump, Infusion
ALARIS SYSTEM WITH GUARDRAILS SUITE MX
| Applicant | Carefusion 303, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 21, 2014 |
| Received | Nov 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133532
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2026 | CareFusion 303, Inc. BD Alaris" System with Guardrails" Suite MX with Point of Care Unit Open, Classified |
FRN | None listed |
| Nov 7, 2023 | CareFusion 303, Inc. BD Alaris PCU REF 8015 Open, Classified |
FRN | None listed |
| Nov 7, 2023 | CareFusion 303, Inc. BD Alaris Syringe Module, REF 8110 Open, Classified |
FRN | None listed |
| Nov 7, 2023 | CareFusion 303, Inc. Alaris PCA Module 8120 Open, Classified |
FRN | None listed |
| Aug 6, 2021 | BioMedical Equipment Service Co (BMES) Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410 Terminated |
FRN | None listed |
| May 10, 2021 | STEP-HAR MEDICAL LLC Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part Terminated |
FRN | None listed |
| Apr 2, 2021 | Tenacore LLC Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part Terminated |
FRN | None listed |
| Apr 2, 2021 | Tenacore LLC Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 Terminated |
FRN | None listed |
| Mar 26, 2021 | Infusion Pump Repair Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part Open, Classified |
FRN | None listed |
| Mar 25, 2021 | The Biomed Guys Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel. Open, Classified |
FRN | None listed |
| Mar 24, 2021 | Pacific Medical Group Inc. Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions) Open, Classified |
FRN | None listed |
| Mar 3, 2021 | CareFusion 303, Inc. BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439. Open, Classified |
FRN | None listed |
| Sep 4, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8015 Open, Classified |
FRN | None listed |
| Sep 4, 2020 | CareFusion 303, Inc. BD Alaris System; Alaris Syringe Module Model 8110;
BD Alaris System; Alaris PCA Module Model 8120;
BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652 Open, Classified |
FRN | None listed |
| Sep 4, 2020 | CareFusion 303, Inc. PC Unit Front Case with Keypad Replacement Kits:
TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS,
TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2,
TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2,
TC10013702 ASSY, CAS Open, Classified |
FRN | None listed |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual st Open, Classified |
FRN | None listed |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual Open, Classified |
FRN | None listed |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual ste Open, Classified |
FRN | None listed |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual s Open, Classified |
FRN | None listed |
| Aug 19, 2020 | CareFusion 303, Inc. Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amou Open, Classified |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris Pump Module Model 8100, a modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris PCA Module Model 8120, a modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8000 modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris System PC Unit Model 8015. modular infusion pump and monitoring system Terminated |
FRN | None listed |
| Aug 6, 2020 | CareFusion 303, Inc. Alaris Pump Module Model 8100 Terminated |
FRN | None listed |
| Aug 4, 2020 | CareFusion 303, Inc. BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump. Open, Classified |
FRN | None listed |
| Aug 4, 2020 | CareFusion 303, Inc. BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate Open, Classified |
PHC | None listed |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) Open, Classified |
FRN | None listed |
| Jul 16, 2019 | CareFusion 303, Inc. Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin.
The following products are affected by this recall as they are pumps or pump assemblies with bezels m Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.