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PRESSURE REGULATOR (2016-03-14)
- Starting date:
- March 14, 2016
- Posting date:
- April 4, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57738
Affected Products
PRESSURE REGULATOR
Reason
The current recommendation of spraying EVICEL (Fibrin Sealant) with the 45 cm tip during laparoscopy surgery is at a pressure range of 1.4 to 1.7bar. The European Medicines Agency have clarified their recommendation for pressure to be used when spraying EVICEL with the 45 cm tip during laparoscopic surgery from a range of 1.4-1.7 bar to 1.4 bar only. A similar approach has been taken in Canada. Thus, the labelling of the pressure regulators will be updated and the sticker label on each pressure regulator will be replaced to reflect this change.
Affected products
PRESSURE REGULATOR
Lot or serial number
All lots.
Model or catalog number
EVRC67
Companies
- Manufacturer
-
Omrix Biopharmaceuticals Ltd.
5510801
ISRAEL