BEUDAMED
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    BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·April 1, 2015

    Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte

    FDA Recall
    Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

    Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte

    FDA Recall
    Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

    Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte

    FDA Recall
    Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

    Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte

    FDA Recall
    Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

    Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte

    FDA Recall
    Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151

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

    MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164

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

    BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.

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

    BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.

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

    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

    Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.

    FDA Recall
    Terminated ·Medical Action Industries Inc·Product code FPA·November 6, 2009

    Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.

    FDA Recall
    Terminated ·Medical Action Industries Inc·Product code FPA·November 6, 2009

    Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.

    FDA Recall
    Terminated ·Medical Action Industries Inc·Product code FPA·November 6, 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 Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FPA·February 19, 2015

    Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDQ·February 16, 2016

    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDQ·March 27, 2018