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VenaSeal Sapheon Closure System (2015-04-28)
- Starting date:
- April 28, 2015
- Posting date:
- May 21, 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-53425
Recalled Products
A. VenaSeal Sapheon Closure System
Reason
Covidien is conducting a voluntary recall of all Sapheon VenaSeal closure systems due to potential for a sterility breach of the outer packaging (pouch) material. A breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray and does not directly affect the sterility of the device components.
Affected products
A. VenaSeal Sapheon Closure System
Lot or serial number
All lots.
Model or catalog number
VS-301
Companies
- Manufacturer
-
Sapheon Inc.
951 Aviation Parkway, Suite 900
Morrisville
27560
North Carolina
UNITED STATES