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
| Applicant | Alaris Medical Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 2, 2001 |
| Received | Jul 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris Pump Module, Model 8100 Open, Classified |
FRN | None listed |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris Syringe Module, Model 8110 Open, Classified |
FRN | None listed |
| Mar 5, 2020 | CareFusion 303, Inc. CareFusion Alaris PCA Module, Model 8120 Open, Classified |
FRN | None listed |
| Aug 3, 2009 | Cardinal 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 |
FRN | None listed |
| Aug 3, 2009 | Cardinal 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 |
FRN | None listed |
| Aug 3, 2009 | Cardinal 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 |
FRN | None listed |
| May 1, 2009 | Cardinal 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 |
FRN | None listed |
| Jun 10, 2008 | Cardinal 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 |
FRN | None listed |
| Jun 10, 2008 | Cardinal 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 |
FRN | None listed |
| Jun 10, 2008 | Cardinal 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 |
FRN | 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 |
| Mar 3, 2005 | Alaris Medical Systems Inc Model 8100 Series Medley Medication Safety System Pump Module Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.