Reported Jun 26, 2019 · Terminated

LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V…

CooperSurgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350

Is this the product you have?

  • LEEP Precision Integrated System 120V
  • Model LP-10-120 Product UsageThe LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities
Lot codes and dates
    • 2018110001
    • 2018110002
    • 2018110003
    • 2018110004
    • 2018110005
    • 2018110006
    • 2018110007
    • 2018110008
    • 2018110011
    • 2018110012
    • 2018110013
    • 2018110014
    • 2018110015
    • 2018110016
    • 2018110017
    • 2018110019
    • 2018110020
    • 2018110021
    • & 2018110022
Amount recalled
19

Where it was sold

Why it was recalled

2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 24, 2020 · Data as of Sep 19, 4:52 PM UTC

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