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U.S. Department of Health and Human Services

Class 2 Device Recall EVICEL

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 Class 2 Recall
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Date Posted October 22, 2012
Recall Status1 Terminated on September 15, 2015
Recall Number Z-0111-2013
Recall Event ID 63254
Premarket Notification
510(K) Number
Product Classification Syringe, Piston - Product Code FMF
Product 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.
Code Information To include all lots and product codes for EVICEL and Omrix pressure regulators.
Recalling Firm/
Ethicon, Inc.
US Highway 22 West
Somerville, New Jersey 08876
For Additional Information Contact Ms. Christie Bielinski
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
TRAINING: Employee Error
Action 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.
Quantity in Commerce 4800 pressure regulators distributed worldwide; 1500 distributed within the US
Distribution Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = OMRIX BIOPHARMACEUTICALS LTD.