ASPEN SURGICAL recalls Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

Recall date

June 3, 2024

Source

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

Recall number

Z-2221-2024

FDA classification

Class II

Brand / firm

ASPEN SURGICAL

Sold / distributed

US Nationwide

Why it was recalled

The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.

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

What was recalled

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101