FDA-Device2015-11-11Class II
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Alcon Research, Ltd.
Hazard
The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
Sold states
Distributed in VT.
Affected count
5 units
Manufactured in
6201 South Fwy, N/A, Fort Worth, TX, United States
Products
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0195-2016Don't want to check this manually?
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