11 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Broselow/Hinkle Pediatric Emergency System Vital Signs Inc. 20 Campus Road Totowa, NJ 07512 USA The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit
FDA Recall
Terminated
·Vital Signs Devices, a GE Healthcare Company·Product code OGL·October 17, 2011
MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.
FDA Enforcement
Class II
·Terminated·Global Healthcare Inc·September 28, 2016
MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.
FDA Recall
Terminated
·Global Healthcare Inc·Product code FMI·August 9, 2016
Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Waltham, MA 02454
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CGL·November 2, 2007
S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.
FDA Recall
Terminated
·Radiometer America Inc·Product code CGL·December 16, 2011
Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CGL·August 11, 2008
Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CGL·November 2, 2007
Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.
FDA Recall
Terminated
·Radiometer America Inc·Product code CGL·March 26, 2009
i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code CGL·March 17, 2010
Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CGL·November 2, 2007
Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.
FDA Recall
Terminated
·Radiometer America Inc·Product code CGL·October 29, 2014