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FDAApril 28, 2015device

The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.

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

The hazard

The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible.

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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The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove. — Recall Details · AllClear