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
Syringe, piston - Product Code FMF
원인
Ethicon and omrix biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer evicel; these events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface. the field correction initiated is to provide the recommend.
조치
Ethicon sent a notification letter "Urgent Product Information EVICEL Fibrin Sealant (Human) All Lots and Product Codes" dated June 27, 2012, to all affected customers. Notifications were sent via UPS on July 2, 2012. The notification informed customers of the identified risks and included instructions for use. The notification included a business reply card consignees were requested to fill out and return.
Customer were notified by a notification titled "Urgent Product Information Omrix Pressure Regulator All Product Codes" that was sent by Ethicon on August 1, 2012, as a follow up to the letter dated June 27, 2012. The notification informed consignees of the identified risks and included instructions for use. Customers were notified that a company representative would visit them to confirm receipt of the notification and to ensure the enclosed label has been affixed correctly on all Omrix Pressure Regulators.
For further questions please call 1-877-384-4266.
Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.
제품 설명
EVICEL Fibrin Sealant (Human) Rx Only. || Manufacturer: || Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. || Distributed by: || Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. || The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.