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Cook Inc. recalls OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usag
Recalled June 21, 2017 · FDA recall Z-2585-2017 · Cook
Hazard
Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. · FDA Class II
Units
10,415
Sold at
Worldwide Distribution - US Nationwide in the states of: AK AL AZ CA CO FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC NJ NY OH OR PA SC SD TN TX WA WI Foreign: Australia, Bolivia, Brazil, Canada, Chile, Columbia, Cyprus, Czech Republic, Germany, Dominican Republic, Greece, Hong Kong, Ireland, Israel, India, Iran, Jordan, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Latvia, Libya, Mexico, Malaysia, New Zealand, Oman, Panama, Peru, Portugal, Serbia, Turkey, Trinidad and Tobago, Taiwan, and Venezuela. VA/DOD: Yes- see below
Description
Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products.
Product
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation
Manufacturer(s)
Cook Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →