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.
데이터 추가 비고
Ligator, esphageal - Product Code MND
원인
A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the patent end of the endoscope. this could result in a section of the ligator barrel detaching inside the patient's gastrointestinal tract.
조치
COOK Endoscopy sent an URGENT: PRODUCT RECALL dated September 3, 2010, via USPS Certified Mail and by email to all consignees. The letter identified the products, the problem, and the action to be taken by the consignees.
All consignees were instructed to quarantine any affected product and return them to Cook Medical. Distributors were instructed to contact their customers and coordinate the return of the affected product to Cook Medical. Within 2 weeks of the initial recall notification, Level B effectiveness checks (40% of the total number of consignees) will be conducted. These customers will receive a recall effectiveness survey. All non-responding consignees will receive a total of 3 recall notifications (2 follow-up requests for a response in addition to the initial recall notification. Monthly status reports regarding this recall will be provided to FDA. All devices returned as part of this recall will be destroyed by the recalling firm upon receipt of authorization to do so by FDA. Forty percent (40%) of total customers affected received a second notice on 9/17/2010 as part of the effectiveness checks. As of 9/21/2010, 38% of all affected customers have responded.
For questions contact the Customer Relations Department at CustomerRelationsNA@cookmedical.com or call 1-800-457-4500, press 4 then enter extension 2146.
Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV, and WY; and the countries of Algeria, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Georgia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Mexico, Malaysia, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, South Africa, Slovakia, Spain, Switzerland, United Arab Emirates, UK and Venezuela.
제품 설명
Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 || This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.