K-204 GUIDE SHEATH KIT 2 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 K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimen…

Recall number

Z-1053-2021

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

K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.