FDA-Device2020-05-27Class II
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
Baylis Medical Company Inc.
Hazard
There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.
Sold states
Product distributed throughout the 50 states and in Washington D.C.
Affected count
Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).
Manufactured in
2645 Matheson Blvd E, N/A, Mississauga, N/A, Canada
Products
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2070-2020Don't want to check this manually?
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