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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 34 of 34 Results
510(K) Number: K133532
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BD Alaris PCU REF 8015 1 11/07/2023 CareFusion 303, Inc.
BD Alaris Syringe Module, REF 8110 1 11/07/2023 CareFusion 303, Inc.
Alaris PCA Module 8120 1 11/07/2023 CareFusion 303, Inc.
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES... 1 08/06/2021 BioMedical Equipment Service Co (BMES)
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bez... 1 06/01/2021 The Biomed Guys
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel rep... 1 05/10/2021 Infusion Pump Repair
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair ... 1 05/10/2021 STEP-HAR MEDICAL LLC
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (... 1 04/19/2021 Pacific Medical Group Inc.
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair ... 1 04/02/2021 Tenacore LLC
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 1 04/02/2021 Tenacore LLC
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacem... 1 04/01/2021 CareFusion 303, Inc.
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/... 1 09/12/2020 CareFusion 303, Inc.
PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC100... 1 09/04/2020 CareFusion 303, Inc.
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120... 1 09/04/2020 CareFusion 303, Inc.
Alaris System PC Unit Model 8015 1 09/04/2020 CareFusion 303, Inc.
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring ... 2 09/03/2020 CareFusion 303, Inc.
Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers... 2 08/19/2020 CareFusion 303, Inc.
Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a... 2 08/19/2020 CareFusion 303, Inc.
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregive... 2 08/19/2020 CareFusion 303, Inc.
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers ... 2 08/19/2020 CareFusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthc... 2 08/19/2020 CareFusion 303, Inc.
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
Alaris Pump Module Model 8100 1 08/06/2020 CareFusion 303, Inc.
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system 1 08/06/2020 CareFusion 303, Inc.
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) 1 03/05/2020 CareFusion 303, Inc.
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. ... 1 07/16/2019 CareFusion 303, Inc.
 
 
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