BEUDAMED
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    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·April 8, 2020

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EQN·December 6, 2019

    Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000282, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.

    FDA Recall
    Terminated ·C R Bard Inc·Product code KGC·January 20, 2009

    ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498447 DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code KGC·March 29, 2010

    ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code KGC·March 29, 2010

    CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code KGC·March 29, 2010

    Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, push; catalog number 6825.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code KGC·June 2, 2005

    18F Tri-Funnel Replacement Gastrostomy Tube

    FDA Recall
    Terminated ·Bard Access Systems, Inc·Product code KGC·April 6, 2006

    24F Tri-Funnel Replacement Gastrostomy Tube

    FDA Recall
    Terminated ·Bard Access Systems, Inc·Product code KGC·April 6, 2006

    22F Tri-Funnel Replacement Gastrostomy Tube

    FDA Recall
    Terminated ·Bard Access Systems, Inc·Product code KGC·April 6, 2006

    Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/2.4 pull; catalog number 6851.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code KGC·June 2, 2005

    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code KGC·September 11, 2015

    Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 pull; catalog number 6848.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code KGC·June 2, 2005

    Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, pull; catalog number 6824.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code KGC·June 2, 2005

    Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.

    FDA Recall
    Terminated ·C R Bard Inc·Product code KGC·January 20, 2009

    ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code KGC·March 29, 2010

    Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/1.7 push; catalog number 6860.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code KGC·June 2, 2005

    Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF 000283, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.

    FDA Recall
    Terminated ·C R Bard Inc·Product code KGC·January 20, 2009

    20F Tri-Funnel Replacement Gastrostomy Tube

    FDA Recall
    Terminated ·Bard Access Systems, Inc·Product code KGC·April 6, 2006

    Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.

    FDA Recall
    Terminated ·C R Bard Inc·Product code KGC·January 20, 2009