Device Recall Customed

  • Modelo / Serial
    Product code 900-787, 25 lots: 109010128 112030747 112052015 112062577 112093733 112114397 112114483 112125114 113015516 113025969 113036383 113047206 113057819 113068181 113078606 113099296 113099577 131110278 131110606 131210973 140111454 140211879 140312331 140412842 140513251
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿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
    GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF || (2) BOWL UTILITY 16oz LIF || (1) TIP CAUTERY POLISHER LIF || (3) TOWELS ABSORBENT 15" X 20" LIF || (1) BOWL UTILITY 32oz || (1) BAG SUTURE FLORAL || (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (2) GOWN IMPERVIOUS REINFORCED LARGE SMS LIF || (1) CAUTERY PENCIL ROCKER SWITCH LIF || (1) BLADE SURGICAL #10 STAINLESS STEEL || (1) TUBE SUCTION CO NNECTING ~" X 12' LIF || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (2) LITE GLOVES LIF || (1) DRAPE LAPAROTOMY WITH POUCH 102" X 121" X 78" STD SMS || (4) DRAPE UTILITY WITH TAPE LIF || (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (1) BLADE SURGICAL #15 CARBON STEEL || (2) SHEET DRAPE 41" X 69" MEDIUM LIF || (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF || 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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