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NRG TRANSSEPTAL NEEDLE
- Starting date:
- October 6, 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-60724
Affected Products
Reason
Through Baylis Medical Company's internal process for non-conforming materials and deviations, a possibility for an integrity defect to the Tyvek Pouch of the NRG TRANSSEPTAL NEEDLE was identified.
Affected products
NRG TRANSSEPTAL NEEDLE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
NRG-71-C1
NRG-E-HF-71-C0
NRG-E-HF-71-C1
NRG-E-HF-98-C0
NRG-HF-71-C0
NRG-HF-71-C1
NRG-HF-98-C1
NTK-710-8545
Companies
- Manufacturer
-
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal
H4T 1A1
Quebec
CANADA