Recall Z-2539-2017 ยท GEX Powered Laser Surgical Instrument
Cook Inc.
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
| Date | Jun 5, 2017 (initiated May 9, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Cook is initiating a voluntary recall of multiple products in the form of a correction to the product Instructions for Use. Cook Inc. has identified the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. Cook distributed notices via courier on May 9, 2017. Customers were i |
| Quantity | 4369 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K124030 | COOK HOLMIUM LASER FIBER Cook Incorporated, Jul 1, 2013 |