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Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack
Recalled December 7, 2022 · FDA recall Z-0354-2023 · Alcon Research
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. · FDA Class II
Units
308,610 kits
Sold at
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.
Description
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.
Product
Alcon Custom Pak Surgical Procedure Pack
Manufacturer(s)
Alcon Research, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →