BEUDAMED
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    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·February 5, 2020

    Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027

    FDA Recall
    Terminated ·Sound Surgical Technologies, LLC·Product code GEI·December 21, 2010

    regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015