FDA-Device2015-06-10Class II
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.
Alcon Research, Ltd.
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.
Sold states
Worldwide Distribution - US Nationwide and the countries of Australia and Canada.
Affected count
219,680 units
Manufactured in
6201 South Fwy, N/A, Fort Worth, TX, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1702-2015Don't want to check this manually?
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