Recall Z-1941-2018— Olsen Medical

Name: FDA recall Z-1941-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-11

Class II · Terminated

Class II FDA medical device recall by Olsen Medical, initiated 2018-05-11, terminated 2019-04-15. It names one FDA 510(k) clearance: K936304. 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.. Reason: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised..

Recalling firm: Olsen Medical
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Terminated: 2019-04-15
Firm location: Louisville, KY, United States

510(k) clearances named in this recall

1 on FDA's record

K936304 — ELECTROSURGICAL PENCILE & M Engineering, Inc.·cleared 1994-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.