FDA Enforcement Class II Terminated

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.

Recall: Z-0111-2013 · Reported October 31, 2012

Enforcement

Recall Number: Z-0111-2013
Event ID: 63254
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Ethicon, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: October 31, 2012
Initiation Date: July 2, 2012
Classification Date: October 22, 2012
Termination Date: September 15, 2015
Address: US Highway 22 West, N/A, Somerville, NJ, 08876, United States

Description

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

Code Info

To include all lots and product codes for EVICEL and Omrix pressure regulators.

Distribution

Worldwide Distribution -- USA (nationwide) and the countries of Canada, European Union, Singapore, Israel, Mexico and Brazil.

Quantity

4800 pressure regulators distributed worldwide; 1500 distributed within the US