Devices

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

  • Model / Serial
    Inner pouch (UPN M00566730) lots 12015222, 12015223, 12017140, 12035930, 12037032, 12038621, 12056814, 12074992, 12096466, 12110667, 12111382, 12111566, 12112012, 12113348, 12129137, 12133028, 12133803 and 12133804  packaged in outer cartons (UPN M00566731) with lot numbers of 12065719, 12065900, 12065903, 12088673, 12105251, 12115743, 12119946, 12145423 and 12148447.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6673, inner pouch UPN M00566730 and outer carton UPN M00566731. || 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

Manufacturer

Boston Scientific Corp
  • Manufacturer Address
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

Device Recall Boston Scientific 20F (6.7 mm) Safety PEG Kit
  • Model / Serial
    Inner pouch (UPN M00566530) packaged in outer cartons (UPN M00566531) with lot number 12080466 on both pouches.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch UPN M00566530 and outer carton UPN M00566531. || 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
Device Recall Boston Scientific 20F (6.7 mm) Safety PEG Kit
  • Model / Serial
    M00566530, Lot Numbers: 11941297 and 11996705; and M00566531, Lot Numbers: 11941297 and 11996705.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, India, Japan and Slovenia.
  • Product Description
    Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6653, inner pouch UPN M00566530 and outer carton UPN M00566531. || 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
Device Recall Boston Scientific 20F (6.7 mm) Safety PEG Kit
  • Model / Serial
    UPN M00566730, Lot Numbers: 11894862, 11897679, 11899718, 11904793, 11905227, 11912161, 11913781, 11913782, 11929586, 11930733, 11935764, 11951838, 11953294, 11964849, 11967137, 11969145, 11970300, 12150268 and 12150824; and UPN M00566731, Lot Numbers: 11903831, 11906396, 11910014, 11910478, 11921219, 11921661, 11928182, 11928186, 11931538, 11939122, 11946172, 11946477, 11949498, 11957027, 11960387, 11978330, 11982282, 11985367, 12005063, 12009465, 12011789, 12019531, 12019534, 12021780, 12025626, 12296086 and 12303610.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, India, Japan and Slovenia.
  • Product Description
    Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6673, inner pouch UPN M00566730 and outer carton UPN M00566731. || 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