Reported Oct 31, 2012 · Terminated
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital,…
Ethicon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, Inc. · US Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- EVICEL Fibrin Sealant (Human) Rx Only
- ManufacturerOmrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603
- Distributed byEthicon, 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
- Lot codes and dates
- To include all lots and product codes for EVICEL and Omrix pressure regulators.
- Amount recalled
- 4800 pressure regulators distributed worldwide; 1500 distributed within the US
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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