Reported May 27, 2020 · Terminated
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590,…
Baylis Medical Company Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baylis Medical Company Inc. · 2645 Matheson Blvd E · Mississauga, N/A · N/A
Is this the product you have?
- NRG RF Transseptal Kit; Model No
- s
NTK-710-8545NTK-710-8555NTK-711-8545NTK-711-8555NTK-711-8590NTK-P711-8545NTK-P711-8555NTK-710-8545SNTK-710-8555SNTK-711-8545SNTK-711-8555SNTK-710-8545NNTK-711-8545N and NTK-711-8555N
- Lot codes and dates
- All lot numbers
- of the following kit model numbers
NTK-710-8545NTK-710-8555NTK-711-8545NTK-711-8555NTK-711-8590NTK-P711-8545NTK-P711-8555NTK-710-8545SNTK-710-8555SNTK-711-8545SNTK-711-8555SNTK-710-8545NNTK-711-8545Nand NTK-711-8555N
- Amount recalled
- Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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