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BIVONA INNER CANNULA (2015-04-20)
- Starting date:
- April 20, 2015
- Posting date:
- May 8, 2015
- 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-53279
Recalled Products
A. BIVONA INNER CANNULA
Reason
Smiths Medical has become aware of the potential for compression of the inner cannula as a result of handling or certain cleaning methods used, outside of the methods described in the IFU. Compression can result in a shorter overall length and may lead to a build-up of secretions within the end of the tracheostomy tube with risk of infection or occlusion. Smiths medical is therefore advising customers of additional information for safe and effective use of Bivona inner cannula.
Affected products
A. BIVONA INNER CANNULA
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
BRC270
BRC275
BRC280
BRC285
BRC290
BRCA70
BRCA75
BRCA80
BRCA85
BRCA90
Companies
- Manufacturer
-
Smiths Medical ASD Inc.
5700W, 23D Ave.
Gary
46406
Indiana
UNITED STATES