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Torflex Transseptal Guiding Sheath (2013-09-24)
- Starting date:
- September 24, 2013
- Posting date:
- October 31, 2013
- 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-36487
Recalled Products
Torflex Transseptal Guiding Sheath
Reason
Small fragment may be scored from the outside of the dilator by the sheath when the dilator is inserted or removed from the sheath. These fragments could potentially migrate into patients bloodstream.
Affected products
Torflex Transseptal Guiding Sheath
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal
H4T 1A1
Quebec
CANADA