ClearanceBrief
510(k) K012383 ยท FRN Pump, Infusion

GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C

ApplicantAlaris Medical Systems, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Oct 2, 2001
ReceivedJul 27, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K012383

DateFirm and productCodeLinked 510(k)
Mar 5, 2020CareFusion 303, Inc.
CareFusion Alaris Pump Module, Model 8100
Open, Classified
FRNNone listed
Mar 5, 2020CareFusion 303, Inc.
CareFusion Alaris Syringe Module, Model 8110
Open, Classified
FRNNone listed
Mar 5, 2020CareFusion 303, Inc.
CareFusion Alaris PCA Module, Model 8120
Open, Classified
FRNNone listed
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above.
Terminated
FRNNone listed
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). The Alaris PC Unit is the central programming
Terminated
FRNNone listed
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patient-Controlled Analges
Terminated
FRNNone listed
May 1, 2009Cardinal Health 303 dba Cardinal Health
Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1.
Terminated
FRNNone listed
Jun 10, 2008Cardinal Health 303 Inc DBA Alaris Products
U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, San Diego, CA 92130
Terminated
FRNNone listed
Jun 10, 2008Cardinal Health 303 Inc DBA Alaris Products
Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Uni
Terminated
FRNNone listed
Jun 10, 2008Cardinal Health 303 Inc DBA Alaris Products
U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe mod
Terminated
FRNNone listed
Sep 19, 2006Cardinal 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
FRNNone listed
Mar 3, 2005Alaris Medical Systems Inc
Model 8100 Series Medley Medication Safety System Pump Module
Terminated
FRNNone listed

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