U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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
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Action to be taken:
1. Examine your inventory immediately to identify and quarantine those affected products.
2. Return the required Acknowledgement and Receipt Form indicating quantities, part numbers, and lot
numbers of affected products within 30 days.
3. Return or discard any affected products. (Instructions regarding product returns are listed in the attached
Acknowledgement and Receipt Form.)
4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt
Form and send it via fax (812.339.7316) or email (fieldactionsna@cookmedical.com).
5. Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or
812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at
customerrelationsna@cookmedical.com.
Adverse events or quality problems experienced with the use of this product may also be reported to the FDA:
Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail)
Call the FDA at: 1-800-FDA-1088
This notice must be shared with appropriate personnel, including down to the user level, within your organization
or to any organization where the potentially affected devices have been transferred. Should you have any medical questions or concerns, please contact
Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
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, Ireland, Israel, India, Iran, Jordan, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Latvia, Libya, Mexico, Malaysia, New Zealand, Oman, Panama, Peru, Portugal, Serbia, Turkey, Trinidad and Tobago, Taiwan, and Venezuela. VA/DOD: Yes- see below
제품 설명
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