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Olsen Medical recalls Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switc
Recalled June 6, 2018 · FDA recall Z-1941-2018 · Olsen Medical
Hazard
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. · FDA Class II
Units
665,350 devices
Sold at
Worldwide Distribution
Description
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Product
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.
Manufacturer(s)
Olsen Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →