ClearanceBrief
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

CodeDeviceRecords
FRNPump, Infusion7
BRYCabinet, Table And Tray, Anesthesia1
FPASet, Administration, Intravascular1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
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
FRNK010966
K012383 +4
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
FRNK010966
K012383 +4
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
FRNK012383
K950419
Jan 4, 2008Cardinal 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
FRNNone listed
Nov 8, 2007Cardinal Health 303 Inc DBA Alaris Products
Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.
Terminated
FPAK053049
Sep 26, 2007Cardinal Health 303 Inc DBA Alaris Products
Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA
Terminated
BRYNone listed
Aug 3, 2007Cardinal 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
FRNK872764
Aug 2, 2007Cardinal 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
FRNK862295
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
FRNK012383
K022209 +3
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