Medical device recalls Moderate risk

CooperSurgical, Inc. recalls LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120

Recall date
June 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2057-2019
FDA classification
Class II
Brand / firm
CooperSurgical, Inc.
Sold / distributed
Nationwide domestic distribution. International distribution to Canada and Costa Rica.

Why it was recalled

The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120

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