Medical device recalls Moderate risk

Genicon, Inc. recalls GENICON EZEE Retrieval, sterile, Rx only.

Recall date
July 19, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1076-2018
FDA classification
Class II
Brand / firm
Genicon, Inc.
Sold / distributed
Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.

Why it was recalled

Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

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

What was recalled

GENICON EZEE Retrieval, sterile, Rx only.

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