BEUDAMED
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    BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·July 31, 2013

    BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

    BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

    BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JSI·June 6, 2013

    LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes

    FDA Recall
    Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

    Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·September 27, 2018

    Iris Sample Processing SafeCrit 75mm Tubes. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.

    FDA Recall
    Terminated ·Drummond Scientific Co·Product code GIO·August 1, 2008

    Centurion IVS3505 ULTRASOUND GUIDED PIV KIT

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

    Iris Sample Processing SafeCrit 40mm Tubes. Catalog number 59-000869-002 H. Iris Sample Processing, 60 Glacier Drive, Westwood, MA 02090. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.

    FDA Recall
    Terminated ·Drummond Scientific Co·Product code GIO·August 1, 2008

    Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.

    FDA Recall
    Terminated ·Drummond Scientific Co·Product code GIO·August 1, 2008

    Separation Technology ClearCRIT Capillary Tubes 75mm/1.1mm ID. Catalog number 270-106. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.

    FDA Recall
    Terminated ·Drummond Scientific Co·Product code GIO·August 1, 2008

    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·December 26, 2018

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·September 27, 2018

    Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·September 27, 2018

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

    FDA Enforcement
    Class II ·Terminated·ICU Medical Inc·October 23, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case

    FDA Recall
    Terminated ·ICU Medical Inc·Product code FRN·July 29, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

    FDA Recall
    Terminated ·ICU Medical Inc·Product code FRN·July 29, 2019