FDA-Device2021-02-17Class II
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Aomori Olympus Co., Ltd.
Hazard
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Sold states
US Nationwide distribution.
Affected count
7,400,000 (globally); 260,395 (US)
Manufactured in
2 Chome 248-1, Okkonoki, Kuroishi, N/A, Japan
Products
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1007-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief