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PERCEVAL SUTURELESS HEART VALVE (2016-08-12)
- Starting date:
- August 12, 2016
- Posting date:
- August 26, 2016
- 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-59986
Affected Products
PERCEVAL SUTURELESS HEART VALVE
Reason
Livanova Canada Corp. (lnc) has identified a manufacturing issue affecting a limited number of perceval valves. These valves were shipped in a sterile packing solution that may contain higher than expected residual levels of homocysteic acid. The homocysteic acid is used during the manufacturing process to neutralize the free aldehydes introduced by the sterilization process.
Affected products
PERCEVAL SUTURELESS HEART VALVE
Lot or serial number
- A29638
- A30436
- A31487
- A31846
Model or catalog number
- PVS21
- PVS23
Companies
- Manufacturer
-
LIVANOVA CANADA CORP.
5005 NORTH FRASER WAY
BURNABY
British Columbia
CANADA