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Cook Inc. recalls Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Recalled June 21, 2017 · FDA recall Z-2539-2017 · Cook
Hazard
Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. · FDA Class II
Units
4369
Sold at
Domestic: AL AR AZ CA CO FL GA HI ID IL IN KY LA MD MI MO MS NC NM NY OH OK OR PA SC TN TX UT VA WA WI Foreign: Austria, Australia, Argentina, Azerbaijan, Belgium, Bulgaria, Bahrain, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Djibouti, Egypt, France, Hong Kong, Honduras, Croatia, Greece, Germany, Hungary, India, Ireland, Italy, Latvia, Malaysia, Morocco, Netherlands, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Spain, Slovenia, South Africa, Sri Lanka, Sweden, Singapore, Taiwan, Thailand, Tunisia, United Kingdom, and Uruguay
Description
Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Product
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Manufacturer(s)
Cook Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →