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    The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IEO·August 5, 2015

    ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IEO·March 30, 2012

    Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IEO·November 13, 2012

    ThermoFisher Scientific Microm STP 420D automated tissue processor.

    FDA Recall
    Terminated ·Thermo Fisher Scientific·Product code IEO·June 3, 2009

    Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IEO·February 9, 2010

    The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IEO·July 27, 2015

    Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0005. This tissue processor prepares tissue samples for sectioning by transforming fixed samples into wax embedded samples. This is achieved by exposing the tissue samples to a sequence of reagents in the processing retorts.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IEO·April 11, 2011

    Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code MOS·April 19, 2010

    Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·August 17, 2022

    EOS, Digital radiography system used in general radiographic examinations.

    FDA Recall
    Terminated ·Eos Imaging Inc·Product code MQB·February 17, 2015

    INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

    FDA Recall
    Terminated ·Ino Therapeutics·Product code MRN·November 30, 2010

    ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000

    FDA Recall
    Terminated ·INO Therapeutics, Inc.·Product code MRN·June 29, 2006

    V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538

    FDA Recall
    Terminated ·Neo Medical, Inc.·Product code LRS·April 5, 2011

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    FDA Recall
    Terminated ·NEO METRICS, INC.·Product code OCY·March 31, 2014

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·NEO METRICS, INC.·June 18, 2014

    ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021

    FDA Enforcement
    Class II ·Terminated·VEO DIAGNOSTICS, LLC·December 9, 2020

    ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·May 20, 2014

    OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE (3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) NEEDLE HYPODERMIC 27G X 'h" (4) COUNTER NEEDLE & BLADE 10c MAG/CLEAR (2) SYRINGE 20cc WITHOUT NDL LUER LOCK LIF (1) JAR 16oz 500cc GRADUATE MEASURE (2) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (2) PENCIL CAUTERY HAND SWITCHING LIF (1) MARKER SKIN RULER (2) BANDAGE ELASTIC 4" X 5yds LIF (2) POLISHER CAUTERY TIP LIF (2) BANDAGE ELASTIC 6" X 5yds LIF (2) SYRINGE BULB 60cc CLEAR (2) TUBE SUCTION CONNECT Y-t'' X 12' LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) NEEDLE BLADE/KNIFE 3.0mm (2) CONTAINER SPECIMEN 40z. WITH LID & LABEL (1) BLADE SHARP ALL ARROUND (1) BASIN EMESIS 10 IN 700cc (3) CATHETER 20FR ROB NEL RED RUB (3) BOWL UTILITY QUART 32oz LIF (2) CATHETER THORACIC 32FR STRAIGH (1) LABELS SET, HEPARINE, SALINE, ETC. (2) SAFETY SCALPEL #10 DISP (3) BASIN WASH ROUND 6QT (2) SAFETY SCALPEL #15 DISP (2) BOWL UTILITY 16oz L/F (1) WRAPPER 54" X 54" L/F (1) CONNECTOR Y 3/8" X 3/8" X 3/8" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

    FDA Recall
    Terminated ·INO Therapeutics (dba Ikaria)·Product code MRN·March 27, 2014