Company
Cardinal Health 303 Inc DBA Alaris Products
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K010966 K012383 +4 |
| 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 | K010966 K012383 +4 |
| 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 | K012383 K950419 |
| Jan 4, 2008 | Cardinal Health 303 Inc DBA Alaris Products Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall) Terminated |
FRN | None listed |
| Nov 8, 2007 | Cardinal Health 303 Inc DBA Alaris Products Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA. Terminated |
FPA | K053049 |
| Sep 26, 2007 | Cardinal Health 303 Inc DBA Alaris Products Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA Terminated |
BRY | None listed |
| Aug 3, 2007 | Cardinal Health 303 Inc DBA Alaris Products Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013 Terminated |
FRN | K872764 |
| Aug 2, 2007 | Cardinal Health 303 Inc DBA Alaris Products All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syring Terminated |
FRN | K862295 |
| 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 | K012383 K022209 +3 |