ClearanceBrief
510(k) K133532 ยท FRN Pump, Infusion

ALARIS SYSTEM WITH GUARDRAILS SUITE MX

ApplicantCarefusion 303, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Aug 21, 2014
ReceivedNov 18, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K133532

DateFirm and productCodeLinked 510(k)
Mar 26, 2026CareFusion 303, Inc.
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Open, Classified
FRNNone listed
Nov 7, 2023CareFusion 303, Inc.
BD Alaris PCU REF 8015
Open, Classified
FRNNone listed
Nov 7, 2023CareFusion 303, Inc.
BD Alaris Syringe Module, REF 8110
Open, Classified
FRNNone listed
Nov 7, 2023CareFusion 303, Inc.
Alaris PCA Module 8120
Open, Classified
FRNNone listed
Aug 6, 2021BioMedical 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
FRNNone listed
May 10, 2021STEP-HAR MEDICAL LLC
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Terminated
FRNNone listed
Apr 2, 2021Tenacore LLC
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
Terminated
FRNNone listed
Apr 2, 2021Tenacore LLC
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Terminated
FRNNone listed
Mar 26, 2021Infusion Pump Repair
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Open, Classified
FRNNone listed
Mar 25, 2021The 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
FRNNone listed
Mar 24, 2021Pacific Medical Group Inc.
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Open, Classified
FRNNone listed
Mar 3, 2021CareFusion 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
FRNNone listed
Sep 4, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8015
Open, Classified
FRNNone listed
Sep 4, 2020CareFusion 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
FRNNone listed
Sep 4, 2020CareFusion 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
FRNNone listed
Aug 19, 2020CareFusion 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
FRNNone listed
Aug 19, 2020CareFusion 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
FRNNone listed
Aug 19, 2020CareFusion 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
FRNNone listed
Aug 19, 2020CareFusion 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
FRNNone listed
Aug 19, 2020CareFusion 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
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Terminated
FRNNone listed
Aug 6, 2020CareFusion 303, Inc.
Alaris Pump Module Model 8100
Terminated
FRNNone listed
Aug 4, 2020CareFusion 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
FRNNone listed
Aug 4, 2020CareFusion 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
PHCNone listed
Mar 5, 2020CareFusion 303, Inc.
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Open, Classified
FRNNone listed
Jul 16, 2019CareFusion 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
FRNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.