Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Reported: June 21, 2017 Initiated: May 9, 2017 #Z-2539-2017
Product Description
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Reason for Recall
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 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 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
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages. Recalled by Cook Inc.. Units affected: 4369.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2539-2017.
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