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FDASeptember 21, 2015device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

alcon researchalcon

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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