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Alcon Research, Ltd. recalls The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed b
Recalled June 10, 2015 · FDA recall Z-1702-2015 · Alcon Research
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. · FDA Class II
Units
219,680 units
Sold at
Worldwide Distribution - US Nationwide and the countries of Australia and Canada.
Description
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.
Product
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.
Manufacturer(s)
Alcon Research, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →