BEUDAMED
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    BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·September 24, 2014

    BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·September 24, 2014

    BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·September 24, 2014

    BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum and zinc determination.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·September 24, 2014

    BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·September 24, 2014

    BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

    BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

    BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum and zinc determination.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

    BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

    BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

    NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·May 1, 2014

    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 25, 2014

    Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 25, 2014

    Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·December 17, 2013

    Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code FJI·February 26, 2016

    Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·June 23, 2014

    BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code JKA·June 23, 2014

    2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 20, 2015

    2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. - Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 20, 2015

    Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·January 18, 2016