INJECTOR FORCEMAX LOWER 4MM recalled over sterility concerns

Recall date

January 4, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Aomori Olympus Co., Ltd. recalls INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic inj…

Recall number

Z-1002-2021

FDA classification

Class II

Brand / firm

Aomori Olympus Co., Ltd.

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - 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.