Device product
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.
Z-2070-2020
Product summary
- Event
- Event 85353
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).
- Official record key
device-enforcement:Z-2070-2020
Official wording
Reason: 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.
Code information: All lot numbers of the following kit model numbers: 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.
Distribution pattern: Product distributed throughout the 50 states and in Washington D.C.
Derived failure modes
-
Labeling or packaging
packaging defect
-
Sterility assurance
sterile packaging of the transseptal guiding sheath to be compromised