Device Recall Customed

  • Modelo / Serial
    Code 900-2715, 1 lot: 113099591
  • Clasificación del producto
  • 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
    Endovascular Pack, code 900-2715, contains: || ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF || (2) TOWELS ABSORBENT 15 X 20 LIF || ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf || (2) BAG BAND FLUOROSCOPE 36 X 30 LIF || ( I) NEEDLE HYPODERMIC 21G X I Y, LIF || (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI III LIF || (2) SOLUTION SURGICAL DURAPREP 6ML LIF || ( I) BAG BAND RUB BAND & TAPE 42 X 38 LIF || (4) TOWELS CLOTH HUCK BLUE LIF || (I) Pr. GLOVE SYNTEGRA CR 6.5 POWDER FREE Llf || (2) Pr. GLOVE SYNTEGRA CR 8 POWDER FREE LIF || ( I) NEEDLE HYPODERMIC 25G X 5/8 LIF || ( I) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK LIF || (I) COYER TABLE 44 X 90 LIF || ( I) SCALPEL WITH HANDLE || (25) GAUZE SPONGES 4 X 4 12PLY LIF || (2) CLAMP TOWEL || (2) SYRINGE I OCC WITHOUT NEEDLE LUER LOCK LIF || ( I) NEEDLE HYPODERMIC 18G X I Y, LIF || ( I) SHARP STOP NEEDLE HOLDER LIF || ( I) TRAY ORGANIZER FULL DEEP || ( I) NEEDLE 18G X 23 || (I) BOWL UTILITY BLUE 16oz LIF || ( I) WRAPPER 24X 24 LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
  • 1 Event

Fabricante

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

331 dispositivos con un nombre similar

Más información acerca de la data acá

  • 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
  • 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
  • Modelo / Serial
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Clasificación del producto
  • 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
  • Modelo / Serial
    LOT: SL15209 (150719960) 31-JUL-16
  • Clasificación del producto
  • 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
  • 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
  • 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
  • Modelo / Serial
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Clasificación del producto
  • 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
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