Olsen Medical recalls Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switch…

Recall date

May 11, 2018

Source

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

Recall number

Z-1941-2018

FDA classification

Class II

Brand / firm

Olsen Medical

Sold / distributed

Worldwide Distribution

Why it was recalled

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being 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

Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25 (g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100 Designed to hold active electrodes.