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THRUPORT VALVE PLACEMENT PACK AND KNOT PUSHER (2015-09-03)
- Starting date:
- September 3, 2015
- Posting date:
- September 29, 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-55134
Recalled Products
- THRUPORT VALVE PLACEMENT PACK
- THRUPORT KNOT PUSHER
Reason
This action has been initiated because the configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot.
Affected products
A. THRUPORT VALVE PLACEMENT PACK
Lot or serial number
- 60022521
Model or catalog number
- VPP
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
UNITED STATES
B. THRUPORT KNOT PUSHER
Lot or serial number
- 59964698
- 59967596
- 59984375
- 60016312
Model or catalog number
- KP1
Product UPC
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
UNITED STATES