Device Recall Broselow/Hinkle Pediatric Emergency System

  • Modèle / numéro de série
    Model Numbers: 7700BIO, 7700GIO, 7700PIO, 7700RIO, 7700WIO, 7700YIO, 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2, 7730BLU5, 7730GRN5, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5, 7730FLY, 7730MOD, 7730ALS and 7730IALS; and Lot Numbers: (2008) 245F through 366F and (2009) 001K through 149K.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.
  • Description du dispositif
    Broselow/Hinkle Pediatric Emergency System; || Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use, || INTRAOSSEUS Module, Product # 7700GIO, Vital Signs, Totowa, NJ. || The Broselow/Hinkle Pediatric Emergency System is a convenience kit that contains various modules/components used for the emergency treatment of pediatric patients. The modules are color coded to accommodate patients of various sizes.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Vital Signs Inc, 20 Campus Rd, Totowa NJ 07512
  • Société-mère du fabricant (2017)
  • Source
    USFDA