Reported Nov 11, 2015 · Terminated

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

Alcon Research, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099

Is this the product you have?

  • Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Lot codes and dates
    • 1792733H
    • 1783925H
    • 1785227H
    • 1786729H
Amount recalled
5 units

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 24, 2016 · Data as of Sep 19, 6:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.