FDA-Device2022-12-07Class II
Alcon Custom Pak Surgical Procedure Pack
Alcon Research, LLC
Hazard
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.
Sold states
Worldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. (foreign) to countries of: Australia, Canada, France, Germany, Italy, Mexico, New Zealand, Portugal and United Kingdom.
Affected count
308,610 kits
Manufactured in
9965 Buffalo Speedway, Houston, TX, United States
Products
Alcon Custom Pak Surgical Procedure Pack
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0354-2023Don't want to check this manually?
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