Alcon Custom Pak Surgical Procedure Pack
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.
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.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0354-2023