Devices

Device Recall Customed

  • Modelo / Serial
    Product code 900-740A, 1 lots: 140312021
  • 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) COVER MAYO STAND REINFORCED UF || (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF || (1) TUBE SUCTION CONNECT ~" X 12' LIF || (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF || (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF || (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F || (1) BLADE SURGICAL# 11 STAINLESS STEEL || (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF || (1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF || (1) PAD ABDOMINAL 8" X 7.5" LIF || (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds LIF || (1) TIME OUT BEACON NON WOVEN LIF || (1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF || (1) COVER TABLE 44" X 90" LIF || (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F || (3) TOWELS ABSORBENT 15" X 20" LIF || (1) BAG SUTURE FLORAL || (1) SHEET DRAPE 70" X 1 00" SMS LIF || (1 0) GAUZE SPONGE 4" X 4" 16PL Y || (1) SOLUTION SURGICAL DURAPREP 26ML LIF || (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI || (1) TUR Y SET 81"2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" UF || (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI || LEVEL Ill 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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