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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