51 results · 22ms · Sources: EU EUDAMED, US FDA

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SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

FDA Recall
Terminated ·Baxter Healthcare Corp.·Product code FRN·September 24, 2013

NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review to archive. The NicVue Software includes the following features and intended uses: Launch Applications, Enter patient information, Import/Export patient information from the Hospital Information System, Move data files, Archive data files on DVD or CDROM.

FDA Recall
Terminated ·CareFusion 209 Inc.·Product code OUG·December 16, 2011

ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code FGE·November 7, 2008

ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code FGE·November 7, 2008

ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Used for drainage of bile within the biliary system.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code FGE·November 7, 2008

ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code FGE·November 7, 2008

Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

Jeanes Hospital Custom Cath Procedure Tray, K09T-08945A, Sterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

University Health System Custom Cardiac Cath Pack, K09T-02178, Srterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, Sterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Manufactured by Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09304, Revision B, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872P, Revision H, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision B, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.

FDA Recall
Terminated ·Sigma·Product code FRN·April 23, 2012