Devices

Device Recall Boston Scientific 20F (6.7 mm) Standard PEG Kit

  • Modèle / numéro de série
    UPN M00568400 and UPN M00568401 Lot Numbers: 11730787 and 12143999.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, India, Japan and Slovenia.
  • Description du dispositif
    Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6840, inner pouch UPN M00568400 and outer carton UPN M00568401. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer
    Boston Scientific Corp
  • 1 Event

Fabricant

Boston Scientific Corp
  • Adresse du fabricant
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source
    USFDA

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Device Recall Boston Scientific 20F (6.7 mm) Standard PEG Kit
  • Modèle / numéro de série
    UPN M00568210 and UPN M00568211 Lot Numbers: 11891623, 11906069, 11906483, 11910447, 11927475, 11927476, 11944992, 11948406, 11957306, 11969142, 11986977, 12000544, 12001423, 12025303, 12029062, 12046704, 12050348, 12061338, 12061541, 12083903, 12085669, 12110668, 12113349, 12114748, 12115371, 12130647, 12132911, 12149324, 12162040, 12162501, 12163811, 12169382, 12170033 and 12170540.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, India, Japan and Slovenia.
  • Description du dispositif
    Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6821, inner pouch UPN M00568210 and outer carton UPN M00568211. || The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
  • Manufacturer
    Boston Scientific Corp