Recall Z-2585-2017 ยท GEX Powered Laser Surgical Instrument
Cook Inc.
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
| Date | May 3, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Cook is initiating a voluntary recall of multiple products because they have identified the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. Notices were sent to customers on May 03, 2017 via courier. Customers were asked to do the following: Please contact your local Cook representative for suggested product alternatives to use. FAR2017-030 Page 2 of 2 Action to be taken: 1. Examine your inventory immediately to identify and quarantine those affected products. 2. Return the required Ackno |
| Quantity | 10,415 |
| Distribution | 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, Domin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073496 | OPTILITE HOLMIUM LASER FIBERS Cook Urological, Inc., Jan 23, 2008 |