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Floseal Hemostatic Matrix (2013-11-12)
- Starting date:
- November 12, 2013
- Posting date:
- January 6, 2014
- 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-37245
Recalled products
- Floseal Hemostatic Matrix
Reason
Baxter has provided customers with an important product information notice regarding floseal hemostatic matrix. An update has been added to the precautionary statement of the instructions for use reminding users of the potential risk of inadvertent intravascular uptake of flowable hemostatic material, particularly during surgical procedures which require exposure and opening of large or multiple veins (Venous Plexi). This may result in life-threatening thromboembolic events, either at the time of application or in the post-operative period. Patient positioning during surgery can result in low or negative venous pressure, leading to hemostat introduction into the patient's blood stream.
Affected products
A. Floseal Hemostatic Matrix
Lot or serial number
All lots
Model or catalog number
- 1501398
Companies
- Manufacturer
-
Baxter Healthcare SA
Zurich
8010
SWITZERLAND