Devices

Device Recall Boston Scientific 20F (8 mm) Safety PEG Kit

Model / Serial
M00566750, Lot Numbers: 11905226, 11916062, 11963680, 12018369 and 12166919; and M00566751, Lot Numbers: 11906394, 11928185, 11949741, 11957023, 12025627, 12069497, 12300004 and 12465518.
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 (8 mm) Safety PEG Kit, Push Method, for use with pre-filled lidocaine syringe, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6675, inner pouch UPN M00566750 and outer carton UPN M00566751. || 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
- Recall of Device Recall Boston Scientific 20F (8 mm) Safety PEG Kit

Manufacturer

Boston Scientific Corp

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

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