Recall Z-0111-2013— Ethicon, Inc.

Name: FDA recall Z-0111-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-02

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2012-07-02, terminated 2015-09-15. It names one FDA 510(k) clearance: K090162. 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.. 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.

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Terminated: 2015-09-15
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K090162 — EVICEL APPLICATION DEVICEOmrix Biopharmaceuticals , Ltd.·cleared 2009-02-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.