Cook Inc. recalls OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage:…

Recall date

May 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2585-2017

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

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, Ire…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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