Recall Z-0111-2013 ยท FMF Syringe, Piston
Ethicon, Inc.
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
| Date | Oct 22, 2012 (initiated Jul 2, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 th |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090162 | EVICEL APPLICATION DEVICE Omrix Biopharmaceuticals , Ltd., Feb 20, 2009 |