Medical device recalls Moderate risk

Alcon Research, Ltd. recalls Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthal…

Recall date
September 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0195-2016
FDA classification
Class II
Brand / firm
Alcon Research, Ltd.
Sold / distributed
Distributed in VT.

Why it was recalled

The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.

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

What was recalled

Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

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