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
Endoscope and/or accessories - Product Code KOG
원인
Teleflex medical received complaints that the bite block can become separated from the handle. if separation occurs, medical intervention may be required to remove the bite block from the patient's trachea or esophagus/gi tract.
조치
Consignees received "Urgent Medical Device Recall Notification" letters on or about 04/03/2011. The letters described the issue and provided recommended actions regarding remaining product and returns. Questions were directed to Customer Service at (866) 804-9881 (US).
Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Singapore, China, Denmark, Netherlands, India, Australia, Japan and the United Kingdom.
제품 설명
Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park, NC. The Teleflex Medical BiteGard Molar Bite Black is a disposable single patient use device that fits between the patients molars to prevent the patient from closing their mouth entirely and from obstructing the Laryngeal Mask Airway (LMA) tube, in the case where one is used.