This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Edwards Intuity Elite Heart Valve Kit
- Starting date:
- February 16, 2017
- Posting date:
- March 10, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62528
Reason
Cutomer notification in response to a potential mislabeling in which a special access programme (SAP) label may be present on the product. The Intuity Elite is commercially approved for sale by Health Canada under licence # 97810. Customers may disregard the SAP sticker as it is no longer in effect.
Affected products
Edwards Intuity Elite Heart Valve Kit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 8300KITB19
- 8300KITB21
- 8300KITB23
- 8300KITB25
- 8300KITB27
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
UNITED STATES