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FEM-FLEX II CANNULA (2015-03-25)
- Starting date:
- March 25, 2015
- Posting date:
- April 27, 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-53079
Recalled Products
- FEM-FLEX II FEMORAL ARTERIAL CANNULA
- FEM-FLEX II VENOUS CANNULA
Reason
Through post market surveillance, Edwards Lifesciences has identified a potential health risk to patients regarding the use of Fem-Flex II femoral arterial cannula, sizes 8, 10, and 12 French only. Edwards has received one customer complaint regarding a released wire, located at the tip area of the cannula, which was identified prior to use. Although the condition does not affect the functionality of the cannula, there is potential patient safety risk if a protruding wire is not detected prior to use.
Affected products
A. FEM-FLEX II FEMORAL ARTERIAL CANNULA
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- FEMII008A
- FEMII008AT
- FEMII010A
- FEMII010AT
- FEMII012A
- FEMII012AT
Companies
- Manufacturer
-
Edwards Lifesciences Llc
1 Edwards Way
Irvine
California
UNITED STATES
B. FEM-FLEX II VENOUS CANNULA
Lot or serial number
- 59723307
- 59751074
- 59796683
- 59849119
- 59849124
- 59873250
- 59873251
- 59873252
- 59890924
Model or catalog number
- FEMII008V
- FEMII010V
- FEMII012V
Companies
- Manufacturer
-
Edwards Lifesciences Llc
1 Edwards Way
Irvine
California
UNITED STATES