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

Inner pouch (UPN M00566530) packaged in outer cartons (UPN M00566531) with lot number 12080466 on both pouches.

Gastroenterology-Urology Devices

2

No

Nationwide.

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.

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.

Gastroenterology-Urology Devices

2

No

Nationwide.

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.

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.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- United States, India, Japan and Slovenia.

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.