PR-V614M 2-LUMEN CANNULA 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 PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the bil…

Recall number

Z-0969-2021

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

PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.