510(k) K023264 ยท FRN Pump, Infusion
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
| Applicant | Alaris Medical Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 19, 2002 |
| Received | Sep 30, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023264
| 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 17, 2017 | CareFusion 303, Inc. Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion.
The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and Terminated |
FRN | None listed |
| Aug 8, 2016 | CareFusion 303, Inc. Alaris Syringe Module Model 8110 with software version 9.15
The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps Terminated |
FRN | None listed |
| Aug 14, 2015 | CareFusion 303, Inc. Alaris Syringe Pump, Model No. 8110. Delivers fluids.
Expansion of Affected Units:
BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100. 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 |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.