Devices

Device Recall Customed

  • Modelo / Serial
    Code 900-2765, 6 lots 112124939 113036441 113056798 113057644 113078320 113088806
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Descripción del producto
    NEURO SPINE PACK || , CODE 900-2765 || CONTENTS: || (l ) DRAPE INCISION 23" X 1 7" || (I) SCALPEL W/HANDLE # 15 S/STEEL || (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART || (I) Pk. STRIP SURGICAL W' X 6" || (I) CAUTERY PENCIL HAND SWITCHING LIF || (4) UTILITY DRAPE W/TAPE L/F || (I) SCALPEL W/HANDLE # 10 S/STEEL || (I) TUBE SUCTION CONNECT W' X I 2' LIF || (I) SKIN MARKER W/RULER || (2) SPECIMEN CONTAINER4oz W/LID & LABEL || (I) SOLUTION SURGICAL DURAPREP 26ML LIF || (I) YANKAUER SUCTION TUBE W/0 VENT LIF || (I) MAYO TRAY LARGE || (2) NEEDLE & BLADE COUNTER lOc MAG/CLEAR || (I) DRAPE INCISE ANTIMICROBIAL 23" X 1 7" LIF || (2) SYRINGE I Occ W/0 NEEDLE LUER LOCK LIF || (I) J VAC RESERVOIR 300ML || (2) LITE GLOVE LIF || (2) CAUTERY TIP POLISHER LIF || (2) TABLE COVER BTC 77" X 110" HD FULL L/F || (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (4) TOWELS ABSORBENT 1 5" X 20" LIF || ( I ) DRAPE T LAPAROTOMY 102" X 78" X 1 21" STD SMS (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || ( I) SUTURE BAG FLORAL || (5) DRAPE 'l'4 ECONOMY 53" X 77" LIF || (3) GOWN IMPERVIOUS EXTRA REI NF. LGE T/WRAP || (I) UTILITY BOWL 1 6oz LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event

Fabricante

Customed, Inc
  • Dirección del fabricante
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Empresa matriz del fabricante (2017)
    Customed Inc
  • Source
    USFDA

331 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Customed
  • Modelo / Serial
    LOTS: SL15197 (150719633) 31-JUL-16 SL15201-01 (150719633)31-JUL-16 SL15201-02 (150719632)31-JUL-16 SL15203 (150719632) 31-JUL-16 SL15240 (150720068) 31-AUG-16 SL15240 (150820069) 31-AUG-16 SL15243 (150820069) 31-AUG-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 9001296 || PREMIUM LAPAROTOMY PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Modelo / Serial
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900169 || UNIVERSAL SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Modelo / Serial
    LOT: SL15209 (150719960) 31-JUL-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 9001738 || UROLOGY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Modelo / Serial
    LOTS: SV15168 (141015851) 31-OCT-15 SL15187 (150619088) 30-JUN-16 SL15187 (150719604) 31-JUL-16 SL15191-01 (150719604) 31-JUL-16 SL15261 (150920134) 30-SEP-16 SL15264 (150920725) 30-SEP-16 SL15264 (150920134) 30-SEP-16
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900010 SUTURE REMOVAL KIT || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Modelo / Serial
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900012 OB SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
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