17 results
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17ms
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Sources: EU EUDAMED, US FDA
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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
a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5% 28DAY QT (16/CS) PSS744 Catalog # 341. d. METREX RESEARCH LLC MetriCide DISINFECTANT, METRICIDE 14DAYGLUTARALDEHYDE 1GL (4/CS) Catalog # 10-1400. e. METREX RESEARCH LLC MetriCide28 DISINFECTANT, METRICIDE GLUT LNG LIFE GL (4GL/CS) Catalog # 10-2800
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code MED·May 25, 2022
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
a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX-1000 METREX Catalog #13-1000. d. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE PUMP SPRAY 24OZ METREX Catalog #13-1024. e. CaviCide1 DISINFECTANT, CLNR CAVICIDE1 24OZ (12/CS) METREX Catalog #13-5024. f. METREX RESEARCH CORP DISINFECTANT, ENVIROCIDE 24OZ(12/CS) METREX Model Number: 13-3324. g. METREX RESEARCH CORP Envirocide DISINFECTANT, ENVIROCIDE GL(4/CS)MX-3300 METREX Model Number: 13-3300
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code LRJ·May 25, 2022
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code CGL·April 24, 2025
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
Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGL·September 11, 2019
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
Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific Medical Philips M1356A Ultrasound M1356A Crystal, NFPH9535
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGL·September 11, 2019
Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGL·September 11, 2019
Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGL·September 11, 2019