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Recall Observatory FDA recall evidence

Device 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.

Z-1941-2018

May 11, 2018

Class II

Product summary

Firm
Olsen Medical
Event
Event 80080
Status
Terminated
Classification
Class II
Quantity
665,350 devices
Official record key
device-enforcement:Z-1941-2018

Official wording

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

Code information: all codes

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    pouch seal thereby increasing the risk of the seal being compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile pouch seal thereby increasing the risk of the seal being compromised