Devices

Device Recall Customed

  • Modelo / Serial
    Product code 900-620, 28 lots: 111113132 111123276 112010192 112020517 112030733 112041340 112052000 112062500 112072808 112083437 112093729 112114579 112124875 113015455 113025964 113036374 113036444 113068176 113088879 113099447 113109862 131210833 140111241 140211733 140211943 140412839 140513377 140513456
  • Clasificación del producto
    General and Plastic Surgery 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
    ARTHROSCOPY PACK - || (1) MAYO STAND COVER REINFORCED LIF || (1 0) GAUZE SPONGES 4" X 4" 16PL Y || (1) TUBE SUCTION CONNECTING X" X 12' LIF || (1) IMP. STOCKINETTE || (1) SURGICAL BLADE #11 STAINLESS STEEL || (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ || (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF || (2) ELASTIC BANDAGE 6" X 5yrd LIF || (1) TUR Y SET 81 "2.1m REGULAR CLAM || (2) NEEDLE HYPODERMIC 18G X 1 ~ || (1) TABLE COVER 50" X 90" REINFORCED LIF || (5) TOWEL ABSORBENT 15" X 20" LIF || (2) DRAPE UTILITY WITH TAPE LIF || (1) DURAPREP SURGICAL SOLUTION 26m I LIF || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT || (1) Pr. NEUTRALON SURGEON GLOVES #7.5 || (1) Pr. NEUTRALON SURGEON GLOVES #8 || (1) Pr. NEUTRALON SURGEON GLOVES #8.5 || (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS || (10) GAUZE SPONGES 4" X 4" 16PLY XRD || (2) STRIPS TAPE || (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF || (1) DRAPE VIDEO CAMERA LIF || 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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