Device product
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Z-2539-2017
Product summary
- Firm
- Cook Inc.
- Event
- Event 77304
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4369
- Official record key
device-enforcement:Z-2539-2017
Official wording
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.
Code information: HLF-M273-H30 HLF-M365-H30 HLF-M550-H30 HLF-M940-H30 HLF-M273-HSMA HLF-M365-HSMA HLF-M550-HSMA HLF-M940-HSMA
Distribution pattern: 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
Derived failure modes
-
Unknown
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.