Field Safety Notice concerning a problem with OMRIX Pressure Regulator to administer Fibrin Sealants, Ethicon, Inc., a Johnson & Johnson company
2010.11.04
Product group Surgical equipment/ Anaesthesia
Reference 03379/10
Ethicon, Inc., a Johnson & Johnson company has issued a Field Safety Notice concerning a problem with OMRIX Pressure Regulator to administer Fibrin Sealants. There may be air or gas embolism, when working in the application of the spray device with higher than recommended pressures and/or with insufficient space on the tissue surface.